Presentations of interest include a
late-breaking abstract on expanded Phase 3 data in BRAF-mutant
metastatic colorectal cancer
Pfizer Inc. (NYSE: PFE) is presenting data across its
industry-leading oncology portfolio, including company-sponsored
and collaborative research studies, spanning 11 therapies in 22
types of cancer, at the European Society for Medical Oncology
(ESMO) Congress to be held in Barcelona, Spain, September 27 -
October 1, 2019. Data from nearly 50 abstracts involving Pfizer
cancer medicines will illustrate the diversity of the portfolio and
the company’s cutting-edge scientific approach. For the first time,
this will include data presentations on compounds from the
acquisition of Array Biopharma Inc.
“At this year’s ESMO Congress, we’re looking forward to
showcasing how we’re embodying ESMO’s theme of translating science
into better patient care,” said Chris Boshoff, M.D., Ph.D., Chief
Development Officer, Oncology, Pfizer Global Product Development.
“Whether it’s studying patient populations such as those affected
by BRAF-mutant metastatic colorectal cancer who are in need of new
treatment options, utilizing new techniques like real-world
evidence to understand further the impact of our medicines in the
non-clinical trial setting, or studying a different way to
administer a treatment that may be more convenient for patients,
Pfizer is leading the way in taking innovative approaches to
meeting the needs of people living with cancer.”
Clinical data can be complex and often difficult to understand
if a person is not a scientist. To help interested non-scientists
better understand the latest research, Pfizer developed summaries
in non-technical language for research results being presented at
this year’s ESMO Congress. These informational materials, called
“abstract plain language summaries (APLS),” will be made available
for non-scientists to learn more about Pfizer’s latest scientific
developments.
Key Pfizer-sponsored abstracts leveraging the depth of Pfizer’s
scientific advances include:
- A late-breaking oral presentation of expanded results from the
Phase 3 BEACON CRC study of BRAFTOVI® (encorafenib) plus cetuximab
with or without MEKTOVI® (binimetinib) in BRAFV600E-mutant
metastatic colorectal cancer (LBA32).
- A poster presentation on real-world clinical practices of
IBRANCE® (palbociclib) plus letrozole vs. letrozole for metastatic
breast cancer (329P).
- A poster presentation on early safety and clinical activity
data of RN888 (PF-06801591) in metastatic non-small cell lung
cancer and urothelial carcinoma (1275P).
- A poster discussion on a subgroup analysis from JAVELIN Renal
101 of BAVENCIO® (avelumab) plus INLYTA® (axitinib) in renal cell
carcinoma patients who did not undergo nephrectomy (908PD).
- A poster discussion on a subgroup analysis from JAVELIN Renal
101 of BAVENCIO® (avelumab) plus INLYTA® (axitinib) in renal cell
carcinoma patients with sarcomatoid histology (910PD).
- A poster discussion on the efficacy of LORBRENA® (lorlatinib)
in the post second-generation ALK tyrosine kinase inhibitor setting
(1487PD).
- A poster presentation on the efficacy of XTANDI® (enzalutamide)
with androgen deprivation therapy in high and low disease volume
and risk groups in patients with metastatic hormone-sensitive
prostate cancer (853P).
Details for key Pfizer-sponsored oral presentations, poster
discussions and poster presentations are below:
Title/Abstract Number
Date/Time (CEST)
Location
(LBA32)
Encorafenib plus Cetuximab With or Without
Binimetinib for BRAF V600E–Mutant Metastatic Colorectal Cancer:
Expanded Results from a Randomized, 3-Arm, Phase III Study vs. the
Choice of Either Irinotecan or FOLFIRI plus Cetuximab (BEACON
CRC)
Tabernero J
Monday, September 30
8:30 AM - 8:45 AM
Barcelona Auditorium
(908PD)
Primary renal tumour shrinkage in patients
(pts) who did not undergo upfront cytoreductive nephrectomy (uCN):
subgroup analysis from the phase 3 JAVELIN Renal 101 trial of
first-line avelumab + axitinib (A + Ax) vs sunitinib (S) for
advanced renal cell carcinoma (aRCC)
Albiges L
Sunday, September 29
3:00 PM – 4:15 PM
Pamplona Auditorium
(910PD)
Efficacy and biomarker analysis of
patients (pts) with advanced renal cell carcinoma (aRCC) with
sarcomatoid histology (sRCC): subgroup analysis from the phase 3
JAVELIN Renal 101 trial of first-line avelumab plus axitinib (A +
Ax) vs sunitinib (S)
Choueiri TK
Sunday, September 29
3:00 PM – 4:15 PM
Pamplona Auditorium
(329P)
Comparative effectiveness of palbociclib
plus letrozole vs letrozole for metastatic breast cancer in US
real-world clinical practices
Layman RM
Sunday, September 29
12:00 PM – 1:00 PM
Hall 4
(1487PD)
Intracranial and extracranial efficacy of
lorlatinib in the post second-generation ALK tyrosine kinase
inhibitor (TKI) setting
Camidge DR
Sunday, September 29
4:30 PM – 5:45 PM
Cordoba Auditorium
(853P)
ARCHES – the role of androgen deprivation
therapy (ADT) with enzalutamide (ENZA) or placebo (PBO) in
metastatic hormone-sensitive prostate cancer (mHSPC): Post hoc
analyses of high and low disease volume and risk groups
Stenzl A
Monday, September 30
12:00 PM – 1:00 PM
Hall 4
(1275P)
Safety and clinical activity of
subcutaneously (SC) administered anti-PD-1 antibody PF-06801591 in
phase I dose-expansion cohorts of locally advanced or metastatic
non-small cell lung cancer (NSCLC) and urothelial carcinoma
(UC)
Cho BC
Monday, September 30
12:00 PM – 1:00 PM
Hall 4
(1360P)
Intracranial anti-tumor activity in
melanoma brain metastases with encorafenib plus binimetinib: a
multicenter, retrospective analysis
Lutzky J
Monday, September 30
12:00 PM – 1:00 PM
Hall 4
(1379TiP)
A phase 2, open-label, randomized,
multicenter trial of encorafenib + binimetinib evaluating a
standard-dose and a high-dose regimen in patients with
BRAFV600-mutant melanoma brain metastasis (MBM) (POLARIS)
Davies MA
Monday, September 30
12:00 PM – 1:00 PM
Hall 4
Please see a complete list of Pfizer-sponsored abstracts
featuring data on our broad pipeline of biologics and small
molecules at https://www.pfizer.com/news/press-kits/oncology.
About BAVENCIO® (avelumab)
In Europe, BAVENCIO® (avelumab)is indicated as monotherapy for
the treatment of adult patients with metastatic Merkel cell
carcinoma (MCC).
In the U.S., BAVENCIO is indicated for:
- Adults and pediatric patients 12 years and older with
metastatic MCC.
- Patients with locally advanced or metastatic urothelial
carcinoma (UC)who:
- Have disease progression during or following
platinum-containing chemotherapy.
- Have disease progression within 12 months of neoadjuvant or
adjuvant treatment with platinum-containing chemotherapy.
- First-line treatment, in combination with axitinib of patients
with advanced renal cell carcinoma.
BAVENCIO Important Safety Information from the U.S.
FDA-Approved Label
BAVENCIO can cause immune-mediated pneumonitis, including
fatal cases. Monitor patients for signs and symptoms of
pneumonitis, and evaluate suspected cases with radiographic
imaging. Administer corticosteroids for Grade 2 or greater
pneumonitis. Withhold BAVENCIO for moderate (Grade 2) and
permanently discontinue for severe (Grade 3), life-threatening
(Grade 4), or recurrent moderate (Grade 2) pneumonitis. Pneumonitis
occurred in 1.2% of patients, including one (0.1%) patient with
Grade 5, one (0.1%) with Grade 4, and five (0.3%) with Grade 3.
BAVENCIO can cause hepatotoxicity and immune-mediated
hepatitis, including fatal cases. Monitor patients for abnormal
liver tests prior to and periodically during treatment. Administer
corticosteroids for Grade 2 or greater hepatitis. Withhold BAVENCIO
for moderate (Grade 2) immune-mediated hepatitis until resolution
and permanently discontinue for severe (Grade 3) or
life-threatening (Grade 4) immune-mediated hepatitis.
Immune-mediated hepatitis occurred with BAVENCIO as a single agent
in 0.9% of patients, including two (0.1%) patients with Grade 5,
and 11 (0.6%) with Grade 3.
BAVENCIO in combination with axitinib can
cause hepatotoxicity with higher than expected frequencies
of Grade 3 and 4 alanine aminotransferase (ALT) and aspartate
aminotransferase (AST) elevation. Consider more frequent monitoring
of liver enzymes as compared to when the drugs are used as
monotherapy. Withhold BAVENCIO and axitinib for moderate (Grade 2)
hepatotoxicity and permanently discontinue the combination for
severe or life-threatening (Grade 3 or 4) hepatotoxicity.
Administer corticosteroids as needed. In patients treated with
BAVENCIO in combination with axitinib, Grades 3 and 4 increased ALT
and AST occurred in 9% and 7% of patients, respectively, and
immune-mediated hepatitis occurred in 7% of patients, including
4.9% with Grade 3 or 4.
BAVENCIO can cause immune-mediated colitis. Monitor
patients for signs and symptoms of colitis. Administer
corticosteroids for Grade 2 or greater colitis. Withhold BAVENCIO
until resolution for moderate or severe (Grade 2 or 3) colitis
until resolution. Permanently discontinue for life-threatening
(Grade 4) or recurrent (Grade 3) colitis upon reinitiation of
BAVENCIO. Immune-mediated colitis occurred in 1.5% of patients,
including seven (0.4%) with Grade 3.
BAVENCIO can cause immune-mediated endocrinopathies,
including adrenal insufficiency, thyroid disorders, and type 1
diabetes mellitus.
Monitor patients for signs and symptoms of
adrenal insufficiency during and after treatment, and
administer corticosteroids as appropriate. Withhold BAVENCIO for
severe (Grade 3) or life-threatening (Grade 4) adrenal
insufficiency. Adrenal insufficiency was reported in 0.5% of
patients, including one (0.1%) with Grade 3.
Thyroid disorders can occur at any
time during treatment. Monitor patients for changes in thyroid
function at the start of treatment, periodically during treatment,
and as indicated based on clinical evaluation. Manage
hypothyroidism with hormone replacement therapy and hyperthyroidism
with medical management. Withhold BAVENCIO for severe (Grade 3) or
life-threatening (Grade 4) thyroid disorders. Thyroid disorders,
including hypothyroidism, hyperthyroidism, and thyroiditis, were
reported in 6% of patients, including three (0.2%) with Grade
3.
Type 1 diabetes mellitus including
diabetic ketoacidosis: Monitor patients for hyperglycemia or other
signs and symptoms of diabetes. Withhold BAVENCIO and administer
antihyperglycemics or insulin in patients with severe or
life-threatening (Grade ≥3) hyperglycemia, and resume treatment
when metabolic control is achieved. Type 1 diabetes mellitus
without an alternative etiology occurred in 0.1% of patients,
including two cases of Grade 3 hyperglycemia.
BAVENCIO can cause immune-mediated nephritis and renal
dysfunction. Monitor patients for elevated serum creatinine
prior to and periodically during treatment. Administer
corticosteroids for Grade 2 or greater nephritis. Withhold BAVENCIO
for moderate (Grade 2) or severe (Grade 3) nephritis until
resolution to Grade 1 or lower. Permanently discontinue BAVENCIO
for life-threatening (Grade 4) nephritis. Immune-mediated nephritis
occurred in 0.1% of patients.
BAVENCIO can result in other severe and fatal immune-mediated
adverse reactions involving any organ system during treatment
or after treatment discontinuation. For suspected immune-mediated
adverse reactions, evaluate to confirm or rule out an
immune-mediated adverse reaction and to exclude other causes.
Depending on the severity of the adverse reaction, withhold or
permanently discontinue BAVENCIO, administer high-dose
corticosteroids, and initiate hormone replacement therapy, if
appropriate. Resume BAVENCIO when the immune-mediated adverse
reaction remains at Grade 1 or lower following a corticosteroid
taper. Permanently discontinue BAVENCIO for any severe (Grade 3)
immune-mediated adverse reaction that recurs and for any
life-threatening (Grade 4) immune-mediated adverse reaction. The
following clinically significant immune-mediated adverse reactions
occurred in less than 1% of 1738 patients treated with BAVENCIO as
a single agent or in 489 patients who received BAVENCIO in
combination with axitinib: myocarditis including fatal cases,
pancreatitis including fatal cases, myositis, psoriasis, arthritis,
exfoliative dermatitis, erythema multiforme, pemphigoid,
hypopituitarism, uveitis, Guillain-Barré syndrome, and systemic
inflammatory response.
BAVENCIO can cause severe or life-threatening
infusion-related reactions. Premedicate patients with an
antihistamine and acetaminophen prior to the first 4 infusions and
for subsequent infusions based upon clinical judgment and
presence/severity of prior infusion reactions. Monitor patients for
signs and symptoms of infusion-related reactions, including
pyrexia, chills, flushing, hypotension, dyspnea, wheezing, back
pain, abdominal pain, and urticaria. Interrupt or slow the rate of
infusion for mild (Grade 1) or moderate (Grade 2) infusion-related
reactions. Permanently discontinue BAVENCIO for severe (Grade 3) or
life-threatening (Grade 4) infusion-related reactions.
Infusion-related reactions occurred in 25% of patients, including
three (0.2%) patients with Grade 4 and nine (0.5%) with Grade
3.
BAVENCIO in combination with axitinib can cause major adverse
cardiovascular events (MACE) including severe and fatal events.
Consider baseline and periodic evaluations of left ventricular
ejection fraction. Monitor for signs and symptoms of cardiovascular
events. Optimize management of cardiovascular risk factors, such as
hypertension, diabetes, or dyslipidemia. Discontinue BAVENCIO and
axitinib for Grade 3-4 cardiovascular events. MACE occurred in 7%
of patients with advanced RCC treated with BAVENCIO in combination
with axitinib compared to 3.4% treated with sunitinib. These events
included death due to cardiac events (1.4%), Grade 3-4 myocardial
infarction (2.8%), and Grade 3-4 congestive heart failure
(1.8%).
BAVENCIO can cause fetal harm when administered to a
pregnant woman. Advise patients of the potential risk to a fetus
including the risk of fetal death. Advise females of childbearing
potential to use effective contraception during treatment with
BAVENCIO and for at least 1 month after the last dose of BAVENCIO.
It is not known whether BAVENCIO is excreted in human milk. Advise
a lactating woman not to breastfeed during treatment and for
at least 1 month after the last dose of BAVENCIO due to the
potential for serious adverse reactions in breastfed infants.
Please see full U.S. Prescribing Information and Medication
Guide for BAVENCIO available at www.Bavencio.com.
About INLYTA® (axitinib)
In Europe, INLYTA® (axitinib) is indicated for the treatment of
adult patients with advanced renal-cell carcinoma (RCC) after
failure of prior treatment with sunitinib or a cytokine.
In the U.S., INLYTA is indicated for the treatment of advanced
RCC after failure of one prior systemic therapy.
INLYTA Important Safety Information from the U.S.
FDA-Approved Label
Hypertension including hypertensive crisis has
been observed with axitinib. Blood pressure should be well
controlled prior to initiating axitinib. Monitor for hypertension
and treat as needed. For persistent hypertension, despite use of
antihypertensive medications, reduce the dose. Discontinue axitinib
if hypertension is severe and persistent despite use of
antihypertensive therapy and dose reduction of axitinib, and
discontinuation should be considered if there is evidence of
hypertensive crisis.
Arterial and venous thrombotic events have been observed
with axitinib and can be fatal. Use with caution in patients who
are at increased risk or who have a history of these events.
Hemorrhagic events, including fatal events, have been
reported with axitinib. Axitinib has not been studied in patients
with evidence of untreated brain metastasis or recent active
gastrointestinal bleeding and should not be used in those patients.
If any bleeding requires medical intervention, temporarily
interrupt the axitinib dose.
Cardiac failure has been observed with axitinib and can
be fatal. Monitor for signs or symptoms of cardiac failure
throughout treatment with axitinib. Management of cardiac failure
may require permanent discontinuation of axitinib.
Gastrointestinal perforation and fistula, including
death, have occurred with axitinib. Use with caution in patients at
risk for gastrointestinal perforation or fistula. Monitor for
symptoms of gastrointestinal perforation or fistula periodically
throughout treatment.
Hypothyroidism requiring thyroid hormone replacement has
been reported with axitinib. Monitor thyroid function before
initiation of, and periodically throughout, treatment.
No formal studies of the effect of axitinib on wound
healing have been conducted. Stop axitinib at least 24 hours
prior to scheduled surgery.
Reversible Posterior Leukoencephalopathy Syndrome (RPLS)
has been observed with axitinib. If signs or symptoms occur,
permanently discontinue treatment.
Proteinuria has been observed with axitinib. Monitor for
proteinuria before initiation of, and periodically throughout,
treatment with axitinib. For moderate to severe proteinuria, reduce
the dose or temporarily interrupt treatment.
Liver enzyme elevation has been observed during treatment
with axitinib. Monitor ALT, AST, and bilirubin before initiation
of, and periodically throughout, treatment.
For patients with moderate hepatic impairment, the
starting dose should be decreased. axitinib has not been studied in
patients with severe hepatic impairment.
Axitinib can cause fetal harm. Advise patients of the
potential risk to the fetus and to use effective contraception
during treatment.
Avoid strong CYP3A4/5 inhibitors. If unavoidable, reduce
the dose. Grapefruit or grapefruit juice may also increase axitinib
plasma concentrations and should be avoided.
Avoid strong CYP3A4/5 inducers and, if possible, avoid
moderate CYP3A4/5 inducers.
Please see full U.S. Prescribing Information for INLYTA at
www.Inlyta.com.
About IBRANCE® (palbociclib)
In Europe, IBRANCE® (palbociclib) is indicated for the treatment
of hormone receptor (HR)-positive, human epidermal growth factor
receptor 2 (HER2)-negative locally advanced or metastatic breast
cancer in combination with an aromatase inhibitor; in combination
with fulvestrant in women who have received prior endocrine
therapy. In pre- or perimenopausal women, the endocrine therapy
should be combined with a luteinizing hormone releasing hormone
agonist.
In the U.S., IBRANCE (palbociclib) 125 mg capsules is indicated
for the treatment of adult patients with HR+/HER2- advanced or
metastatic breast cancer in combination with an aromatase inhibitor
as initial endocrine-based therapy in postmenopausal women or in
men; or fulvestrant in patients with disease progression following
endocrine therapy.
IBRANCE Important Safety Information from the U.S.
FDA-Approved Label
Neutropenia was the most frequently reported adverse
reaction in PALOMA-2 (80%) and PALOMA-3 (83%). In PALOMA-2, Grade 3
(56%) or 4 (10%) decreased neutrophil counts were reported in
patients receiving IBRANCE plus letrozole. In PALOMA-3, Grade 3
(55%) or Grade 4 (11%) decreased neutrophil counts were reported in
patients receiving IBRANCE plus fulvestrant. Febrile neutropenia
has been reported in 1.8% of patients exposed to IBRANCE across
PALOMA-2 and PALOMA-3. One death due to neutropenic sepsis was
observed in PALOMA-3. Inform patients to promptly report any
fever.
Monitor complete blood count prior to starting IBRANCE, at the
beginning of each cycle, on Day 15 of first 2 cycles and as
clinically indicated. Dose interruption, dose reduction, or delay
in starting treatment cycles is recommended for patients who
develop Grade 3 or 4 neutropenia.
Severe, life-threatening, or fatal interstitial lung disease
(ILD) and/or pneumonitis can occur in patients treated with
CDK4/6 inhibitors, including IBRANCE when taken in combination with
endocrine therapy. Across clinical trials (PALOMA-1, PALOMA-2,
PALOMA-3), 1.0% of IBRANCE-treated patients had ILD/pneumonitis of
any grade, 0.1% had Grade 3 or 4, and no fatal cases were reported.
Additional cases of ILD/pneumonitis have been observed in the
post-marketing setting, with fatalities reported.
Monitor patients for pulmonary symptoms indicative of
ILD/pneumonitis (e.g. hypoxia, cough, dyspnea). In patients who
have new or worsening respiratory symptoms and are suspected to
have developed pneumonitis, interrupt IBRANCE immediately and
evaluate the patient. Permanently discontinue IBRANCE in patients
with severe ILD or pneumonitis.
Based on the mechanism of action, IBRANCE can cause fetal
harm. Advise females of reproductive potential to use effective
contraception during IBRANCE treatment and for at least 3 weeks
after the last dose. IBRANCE may impair fertility in males
and has the potential to cause genotoxicity. Advise male patients
to consider sperm preservation before taking IBRANCE. Advise male
patients with female partners of reproductive potential to use
effective contraception during IBRANCE treatment and for 3 months
after the last dose. Advise females to inform their healthcare
provider of a known or suspected pregnancy. Advise women not to
breastfeed during IBRANCE treatment and for 3 weeks after the
last dose because of the potential for serious adverse reactions in
nursing infants.
The most common adverse reactions (≥10%) of any
grade reported in PALOMA-2 for IBRANCE plus letrozole vs
placebo plus letrozole were neutropenia (80% vs 6%), infections
(60% vs 42%), leukopenia (39% vs 2%), fatigue (37% vs 28%), nausea
(35% vs 26%), alopecia (33% vs 16%), stomatitis (30% vs 14%),
diarrhea (26% vs 19%), anemia (24% vs 9%), rash (18% vs 12%),
asthenia (17% vs 12%), thrombocytopenia (16% vs 1%), vomiting (16%
vs 17%), decreased appetite (15% vs 9%), dry skin (12% vs 6%),
pyrexia (12% vs 9%), and dysgeusia (10% vs 5%).
The most frequently reported Grade ≥3 adverse reactions
(≥5%) in PALOMA-2 for IBRANCE plus letrozole vs placebo
plus letrozole were neutropenia (66% vs 2%), leukopenia (25% vs
0%), infections (7% vs 3%), and anemia (5% vs 2%).
Lab abnormalities of any grade occurring in
PALOMA-2 for IBRANCE plus letrozole vs placebo plus
letrozole were decreased WBC (97% vs 25%), decreased neutrophils
(95% vs 20%), anemia (78% vs 42%), decreased platelets (63% vs
14%), increased aspartate aminotransferase (52% vs 34%), and
increased alanine aminotransferase (43% vs 30%).
The most common adverse reactions (≥10%) of any grade
reported in PALOMA-3 for IBRANCE plus fulvestrant vs placebo
plus fulvestrant were neutropenia (83% vs 4%), leukopenia (53% vs
5%), infections (47% vs 31%), fatigue (41% vs 29%), nausea (34% vs
28%), anemia (30% vs 13%), stomatitis (28% vs 13%), diarrhea (24%
vs 19%), thrombocytopenia (23% vs 0%), vomiting (19% vs 15%),
alopecia (18% vs 6%), rash (17% vs 6%), decreased appetite (16% vs
8%), and pyrexia (13% vs 5%).
The most frequently reported Grade ≥3 adverse reactions
(≥5%) in PALOMA-3 for IBRANCE plus fulvestrant vs
placebo plus fulvestrant were neutropenia (66% vs 1%) and
leukopenia (31% vs 2%).
Lab abnormalities of any grade occurring in
PALOMA-3 for IBRANCE plus fulvestrant vs placebo plus
fulvestrant were decreased WBC (99% vs 26%), decreased neutrophils
(96% vs 14%), anemia (78% vs 40%), decreased platelets (62% vs
10%), increased aspartate aminotransferase (43% vs 48%), and
increased alanine aminotransferase (36% vs 34%).
Avoid concurrent use of strong CYP3A inhibitors. If
patients must be administered a strong CYP3A inhibitor, reduce the
IBRANCE dose to 75 mg. If the strong inhibitor is discontinued,
increase the IBRANCE dose (after 3-5 half-lives of the inhibitor)
to the dose used prior to the initiation of the strong CYP3A
inhibitor. Grapefruit or grapefruit juice may increase plasma
concentrations of IBRANCE and should be avoided. Avoid concomitant
use of strong CYP3A inducers. The dose of sensitive CYP3A
substrates with a narrow therapeutic index may need to be
reduced as IBRANCE may increase their exposure.
For patients with severe hepatic impairment (Child-Pugh
class C), the recommended dose of IBRANCE is 75 mg. The
pharmacokinetics of IBRANCE have not been studied in
patients requiring hemodialysis.
Please see full U.S. Prescribing Information for IBRANCE at
www.Ibrance.com.
About XTANDI® (enzalutamide)
In Europe, XTANDI® (enzalutamide) is indicated for the treatment
of adult men with high-risk non-metastatic castration-resistant
prostate cancer (CRPC); the treatment of adult men with metastatic
CRPC who are asymptomatic or mildly symptomatic after failure of
androgen deprivation therapy in whom chemotherapy is not yet
clinically indicated; the treatment of adult men with metastatic
CRPC whose disease has progressed on or after docetaxel
therapy.
In the U.S., XTANDI is indicated for the treatment of patients
with CRPC.
XTANDI Important Safety Information from the U.S.
FDA-Approved Label
Warnings and Precautions
Seizure occurred in 0.4% of patients receiving XTANDI in
clinical studies. In a study of patients with predisposing factors
for seizure, 2.2% of XTANDI-treated patients experienced a seizure.
Patients in the study had one or more of the following
pre-disposing factors: use of medications that may lower the
seizure threshold; history of traumatic brain or head injury,
cerebrovascular accident or transient ischemic attack, Alzheimer's
disease, meningioma, or leptomeningeal disease from prostate
cancer, unexplained loss of consciousness within the last 12
months, history of seizure, presence of a space occupying lesion of
the brain, history of arteriovenous malformation, or history of
brain infection. It is unknown whether anti-epileptic medications
will prevent seizures with XTANDI. Advise patients of the risk of
developing a seizure while taking XTANDI and of engaging in any
activity where sudden loss of consciousness could cause serious
harm to themselves or others. Permanently discontinue XTANDI in
patients who develop a seizure during treatment.
Posterior Reversible Encephalopathy Syndrome (PRES) In
post-approval use, there have been reports of PRES in patients
receiving XTANDI. PRES is a neurological disorder which can present
with rapidly evolving symptoms including seizure, headache,
lethargy, confusion, blindness, and other visual and neurological
disturbances, with or without associated hypertension. A diagnosis
of PRES requires confirmation by brain imaging, preferably MRI.
Discontinue XTANDI in patients who develop PRES.
Hypersensitivity reactions, including edema of the face
(0.5%), tongue (0.1%), or lip (0.1%) have been observed with XTANDI
in clinical trials. Pharyngeal edema has been reported in
post-marketing cases. Advise patients who experience any symptoms
of hypersensitivity to temporarily discontinue XTANDI and promptly
seek medical care. Permanently discontinue XTANDI for serious
hypersensitivity reactions.
Ischemic Heart Disease In the placebo-controlled clinical
studies, ischemic heart disease occurred more commonly in patients
on the XTANDI arm compared to patients on the placebo arm (2.7% vs
1.2%). Grade 3-4 ischemic events occurred in 1.2% of patients on
XTANDI versus 0.5% on placebo. Ischemic events led to death in 0.4%
of patients on XTANDI compared to 0.1% on placebo. Monitor for
signs and symptoms of ischemic heart disease. Optimize management
of cardiovascular risk factors, such as hypertension, diabetes, or
dyslipidemia. Discontinue XTANDI for Grade 3-4 ischemic heart
disease.
Falls and Fractures In the placebo-controlled clinical
studies, falls occurred in 10% of patients treated with XTANDI
compared to 4% of patients treated with placebo. Fractures occurred
in 8% of patients treated with XTANDI and in 3% of patients treated
with placebo. Evaluate patients for fracture and fall risk. Monitor
and manage patients at risk for fractures according to established
treatment guidelines and consider use of bone-targeted agents.
Embryo-Fetal Toxicity Safety and efficacy of XTANDI have
not been established in females. XTANDI can cause fetal harm and
loss of pregnancy when administered to a pregnant female. Advise
males with female partners of reproductive potential to use
effective contraception during treatment with XTANDI and for 3
months after the last dose of XTANDI. XTANDI should not be handled
by females who are or may become pregnant.
Adverse Reactions
The most common adverse reactions (≥ 10%) that occurred more
frequently (≥ 2% over placebo) in the XTANDI patients from the
randomized placebo-controlled trials were asthenia/fatigue,
decreased appetite, hot flush, arthralgia, dizziness/vertigo,
hypertension, headache and weight decreased. In the
bicalutamide-controlled study, the most common adverse reactions (≥
10%) reported in XTANDI patients were asthenia/fatigue, back pain,
musculoskeletal pain, hot flush, hypertension, nausea,
constipation, diarrhea, upper respiratory tract infection, and
weight loss.
In the placebo-controlled study of metastatic CRPC (mCRPC)
patients taking XTANDI who previously received docetaxel, Grade 3
and higher adverse reactions were reported among 47% of XTANDI
patients and 53% of placebo patients. Discontinuations due to
adverse events were reported for 16% of XTANDI patients and 18% of
placebo patients. In the placebo-controlled study of
chemotherapy-naïve mCRPC patients, Grade 3-4 adverse reactions were
reported in 44% of XTANDI patients and 37% of placebo patients.
Discontinuations due to adverse events were reported for 6% of both
study groups. In the placebo-controlled study of non-metastatic
CRPC (nmCRPC) patients, Grade 3 or higher adverse reactions were
reported in 31% of XTANDI patients and 23% of placebo patients.
Discontinuations with an adverse event as the primary reason were
reported for 9% of XTANDI patients and 6% of placebo patients. In
the bicalutamide-controlled study of chemotherapy-naïve mCRPC
patients, Grade 3-4 adverse reactions were reported in 39% of
XTANDI patients and 38% of bicalutamide patients. Discontinuations
with an AE as the primary reason were reported for 8% of XTANDI
patients and 6% of bicalutamide patients.
Lab Abnormalities: In the two placebo-controlled trials
in patients with mCRPC, Grade 1-4 neutropenia occurred in 15% of
XTANDI patients (1% Grade 3-4) and 6% of placebo patients (0.5%
Grade 3-4). In the placebo-controlled trial in patients with
nmCRPC, Grade 1-4 neutropenia occurred in 8% of patients receiving
XTANDI (0.5% Grade 3-4) and in 5% of patients receiving placebo
(0.2% Grade 3-4).
Hypertension: In the two placebo-controlled trials in
patients with mCRPC, hypertension was reported in 11% of XTANDI
patients and 4% of placebo patients. Hypertension led to study
discontinuation in <1% of patients in each arm. In the
placebo-controlled trial in patients with nmCRPC, hypertension was
reported in 12% of patients receiving XTANDI and 5% of patients
receiving placebo.
Drug Interactions
Effect of Other Drugs on XTANDI Avoid strong CYP2C8
inhibitors, as they can increase the plasma exposure to XTANDI. If
co-administration is necessary, reduce the dose of XTANDI. Avoid
strong CYP3A4 inducers as they can decrease the plasma exposure to
XTANDI. If co-administration is necessary, increase the dose of
XTANDI.
Effect of XTANDI on Other Drugs Avoid CYP3A4, CYP2C9, and
CYP2C19 substrates with a narrow therapeutic index, as XTANDI may
decrease the plasma exposures of these drugs. If XTANDI is
co-administered with warfarin (CYP2C9 substrate), conduct
additional INR monitoring.
Please see full U.S. Prescribing Information for XTANDI at
www.Xtandi.com.
About LORBRENA® (lorlatinib)
In Europe, LORBRENA® (lorlatinib) is marketed as LORVIQUA® and
is indicated as monotherapy for the treatment of adult patients
with ALK-positive advanced non-small cell lung cancer (NSCLC) whose
disease has progressed after alectinib or ceritinib as the first
ALK tyrosine kinase inhibitor (TKI) therapy, or crizotinib and at
least one other ALK TKI.
In the U.S., LORBRENA is indicated for the treatment of patients
with ALK-positive metastatic NSCLC whose disease has progressed on
crizotinib and at least one other ALK inhibitor for metastatic
disease; or whose disease has progressed on alectinib or ceritinib
as the first ALK inhibitor therapy for metastatic disease.
This indication is approved under accelerated approval based on
tumor response rate and duration of response. Continued approval
for this indication may be contingent upon verification and
description of clinical benefit in a confirmatory trial.
LORBRENA Important Safety Information from the U.S.
FDA-Approved Label
Contraindications: LORBRENA is contraindicated in
patients taking strong CYP3A inducers, due to the potential for
serious hepatotoxicity.
Risk of Serious Hepatotoxicity with Concomitant Use of Strong
CYP3A Inducers: Severe hepatotoxicity occurred in 10 of 12
healthy subjects receiving a single dose of LORBRENA with multiple
daily doses of rifampin, a strong CYP3A inducer. Grade 4 ALT or AST
elevations occurred in 50% of subjects, Grade 3 in 33% of subjects,
and Grade 2 in 8% of subjects. Discontinue strong CYP3A inducers
for 3 plasma half-lives of the strong CYP3A inducer prior to
initiating LORBRENA. Avoid concomitant use of LORBRENA with
moderate CYP3A inducers. If concomitant use of moderate CYP3A
inducers cannot be avoided, monitor AST, ALT, and bilirubin 48
hours after initiating LORBRENA and at least 3 times during the
first week after initiating LORBRENA. Depending upon the relative
importance of each drug, discontinue LORBRENA or the CYP3A inducer
for persistent Grade 2 or higher hepatotoxicity.
Central Nervous System (CNS) Effects: A broad spectrum of
CNS effects can occur. These include seizures, hallucinations, and
changes in cognitive function, mood (including suicidal ideation),
speech, mental status, and sleep. Withhold and resume at the same
or reduced dose or permanently discontinue based on severity.
Hyperlipidemia: Increases in serum cholesterol and
triglycerides can occur. Grade 3 or 4 elevations in total
cholesterol occurred in 17% and Grade 3 or 4 elevations in
triglycerides occurred in 17% of the 332 patients who received
LORBRENA. Eighty percent of patients required initiation of
lipid-lowering medications, with a median time to onset of start of
such medications of 21 days. Initiate or increase the dose of
lipid-lowering agents in patients with hyperlipidemia. Monitor
serum cholesterol and triglycerides before initiating LORBRENA, 1
and 2 months after initiating LORBRENA, and periodically
thereafter. Withhold and resume at same dose for the first
occurrence; resume at same or reduced dose of LORBRENA for
recurrence based on severity.
Atrioventricular (AV) Block: PR interval prolongation and
AV block can occur. In 295 patients who received LORBRENA at a dose
of 100 mg orally once daily and who had a baseline
electrocardiography (ECG), 1% experienced AV block and 0.3%
experienced Grade 3 AV block and underwent pacemaker placement.
Monitor ECG prior to initiating LORBRENA and periodically
thereafter. Withhold and resume at reduced or same dose in patients
who undergo pacemaker placement. Permanently discontinue for
recurrence in patients without a pacemaker.
Interstitial Lung Disease (ILD)/Pneumonitis: Severe or
life-threatening pulmonary adverse reactions consistent with
ILD/pneumonitis can occur. ILD/pneumonitis occurred in 1.5% of
patients, including Grade 3 or 4 ILD/pneumonitis in 1.2% of
patients. Promptly investigate for ILD/pneumonitis in any patient
who presents with worsening of respiratory symptoms indicative of
ILD/pneumonitis. Immediately withhold LORBRENA in patients with
suspected ILD/pneumonitis. Permanently discontinue LORBRENA for
treatment-related ILD/pneumonitis of any severity.
Embryo-fetal Toxicity: LORBRENA can cause fetal harm.
Advise pregnant women of the potential risk to a fetus. Advise
females of reproductive potential to use an effective non-hormonal
method of contraception, since LORBRENA can render hormonal
contraceptives ineffective, during treatment with LORBRENA and for
at least 6 months after the final dose. Advise males with female
partners of reproductive potential to use effective contraception
during treatment with LORBRENA and for 3 months after the final
dose.
Adverse Reactions: Serious adverse reactions occurred in
32% of the 295 patients; the most frequently reported serious
adverse reactions were pneumonia (3.4%), dyspnea (2.7%), pyrexia
(2%), mental status changes (1.4%), and respiratory failure (1.4%).
Fatal adverse reactions occurred in 2.7% of patients and included
pneumonia (0.7%), myocardial infarction (0.7%), acute pulmonary
edema (0.3%), embolism (0.3%), peripheral artery occlusion (0.3%),
and respiratory distress (0.3%). The most common (≥20%) adverse
reactions were edema, peripheral neuropathy, cognitive effects,
dyspnea, fatigue, weight gain, arthralgia, mood effects, and
diarrhea; the most common (≥20%) laboratory abnormalities were
hypercholesterolemia, hypertriglyceridemia, anemia, hyperglycemia,
increased AST, hypoalbuminemia, increased ALT, increased lipase,
and increased alkaline phosphatase.
Drug Interactions: LORBRENA is contraindicated in
patients taking strong CYP3A inducers. Avoid concomitant use with
moderate CYP3A inducers and strong CYP3A inhibitors. If concomitant
use of moderate CYP3A inducers cannot be avoided, monitor ALT, AST,
and bilirubin as recommended. If concomitant use with a strong
CYP3A inhibitor cannot be avoided, reduce the LORBRENA dose as
recommended. Concomitant use of LORBRENA decreases the
concentration of CYP3A substrates.
Lactation: Because of the potential for serious adverse
reactions in breastfed infants, instruct women not to breastfeed
during treatment with LORBRENA and for 7 days after the final
dose.
Hepatic Impairment: No dose adjustment is recommended for
patients with mild hepatic impairment. The recommended dose of
LORBRENA has not been established for patients with moderate or
severe hepatic impairment.
Renal Impairment: No dose adjustment is recommended for
patients with mild or moderate renal impairment. The recommended
dose of LORBRENA has not been established for patients with severe
renal impairment.
Please see full U.S. Prescribing Information for LORBRENA® at
www.Lorbrena.com.
About BRAFTOVI® (encorafenib) and MEKTOVI®
(binimetinib)
In Europe, BRAFTOVI® (encorafenib) and MEKTOVI® (binimetinib)
are indicated for the treatment of adult patients with unresectable
or metastatic melanoma with a BRAFV600 mutation.
In the U.S., BRAFTOVI and MEKTOVI are indicated for the
treatment of patients with unresectable or metastatic melanoma with
a BRAF V600E or V600K mutation, as detected by an FDA-approved
test.
BRAFTOVI and MEKTOVI Important Safety Information from the
U.S. FDA-Approved Label
WARNINGS AND PRECAUTIONS
New Primary Malignancies, cutaneous and non-cutaneous
malignancies can occur. In the COLUMBUS trial, cutaneous squamous
cell carcinoma (cuSCC), including keratoacanthoma (KA), occurred in
2.6% and basal cell carcinoma occurred in 1.6% of patients. Median
time to first occurrence of cuSCC/KA was 5.8 months. Perform
dermatologic evaluations prior to initiating treatment, every 2
months during treatment, and for up to 6 months following
discontinuation of treatment. Manage suspicious skin lesions with
excision and dermatopathologic evaluation. Dose modification is not
recommended for new primary cutaneous malignancies. Based on its
mechanism of action, BRAFTOVI may promote malignancies associated
with activation of RAS through mutation or other mechanisms.
Monitor patients receiving BRAFTOVI for signs and symptoms of
non-cutaneous malignancies. Discontinue BRAFTOVI for RAS
mutation-positive non-cutaneous malignancies.
Tumor Promotion in BRAF Wild-Type Tumors: In vitro
experiments have demonstrated paradoxical activation of MAP-kinase
signaling and increased cell proliferation in BRAF wild-type cells
exposed to BRAF inhibitors. Confirm evidence of BRAF V600E or V600K
mutation using an FDA-approved test prior to initiating
BRAFTOVI.
Cardiomyopathy, manifesting as left ventricular
dysfunction associated with symptomatic or asymptomatic decreases
in ejection fraction, has been reported in patients. In the
COLUMBUS trial, evidence of cardiomyopathy occurred in 7% and Grade
3 left ventricular dysfunction occurred in 1.6% of patients. The
median time to first occurrence of left ventricular dysfunction
(any grade) was 3.6 months. Cardiomyopathy resolved in 87% of
patients. Assess left ventricular ejection fraction (LVEF) by
echocardiogram or multi-gated acquisition (MUGA) scan prior to
initiating treatment, 1 month after initiating treatment, and then
every 2 to 3 months during treatment. The safety has not been
established in patients with a baseline ejection fraction that is
either below 50% or below the institutional lower limit of normal
(LLN). Patients with cardiovascular risk factors should be
monitored closely. Withhold, reduce dose, or permanently
discontinue based on severity of adverse reaction.
Venous Thromboembolism (VTE): In the COLUMBUS trial, VTE
occurred in 6% of patients, including 3.1% of patients who
developed pulmonary embolism. Withhold, reduce dose, or permanently
discontinue based on severity of adverse reaction.
Hemorrhage: Hemorrhage can occur when BRAFTOVI is
administered in combination with MEKTOVI. In the COLUMBUS trial,
hemorrhage occurred in 19% of patients and ≥ Grade 3 hemorrhage
occurred in 3.2% of patients. The most frequent hemorrhagic events
were gastrointestinal, including rectal hemorrhage (4.2%),
hematochezia (3.1%), and hemorrhoidal hemorrhage (1%). Fatal
intracranial hemorrhage in the setting of new or progressive brain
metastases occurred in 1.6% of patients. Withhold, reduce dose, or
permanently discontinue based on severity of adverse reaction.
Ocular Toxicities: In the COLUMBUS trial, serous
retinopathy occurred in 20% of patients; 8% were retinal detachment
and 6% were macular edema. Symptomatic serous retinopathy occurred
in 8% of patients with no cases of blindness. The median time to
onset of the first event of serous retinopathy (all grades) was 1.2
months. Retinal vein occlusion (RVO) is a known class-related
adverse reaction of MEK inhibitors and may occur in patients
treated with MEKTOVI in combination with encorafenib. In patients
with BRAF mutation-positive melanoma receiving MEKTOVI with
BRAFTOVI (n=690), 1 patient experienced RVO (0.1%). The safety of
MEKTOVI has not been established in patients with a history of RVO
or current risk factors for RVO including uncontrolled glaucoma or
a history of hyperviscosity or hypercoagulability syndromes.
Perform ophthalmological evaluation for patient-reported acute
vision loss or other visual disturbance within 24 hours.
Permanently discontinue MEKTOVI in patients with documented RVO. In
COLUMBUS, uveitis, including iritis and iridocyclitis was reported
in 4% of patients treated with MEKTOVI in combination with
BRAFTOVI. Assess for visual symptoms at each visit. Perform an
ophthalmological evaluation at regular intervals and for new or
worsening visual disturbances, and to follow new or persistent
ophthalmologic findings. Withhold, reduce dose, or permanently
discontinue based on severity of adverse reaction.
Interstitial Lung Disease (ILD): ILD, including
pneumonitis occurred in 0.3% (2 of 690 patients) with BRAF
mutation-positive melanoma receiving MEKTOVI with BRAFTOVI. Assess
new or progressive unexplained pulmonary symptoms or findings for
possible ILD. Withhold, reduce dose, or permanently discontinue
based on severity of adverse reaction.
Hepatotoxicity: Hepatotoxicity can occur when MEKTOVI is
administered in combination with BRAFTOVI. In the COLUMBUS trial,
the incidence of Grade 3 or 4 increases in liver function
laboratory tests was 6% for alanine aminotransferase (ALT), 2.6%
for aspartate aminotransferase (AST), and 0.5% for alkaline
phosphatase. No patient experienced Grade 3 or 4 serum bilirubin
elevation. Monitor liver laboratory tests before initiation of
MEKTOVI, monthly during treatment, and as clinically indicated.
Withhold, reduce dose, or permanently discontinue based on severity
of adverse reaction.
Rhabdomyolysis: Rhabdomyolysis can occur when MEKTOVI is
administered in combination with BRAFTOVI. In the COLUMBUS trial,
elevation of laboratory values of serum CPK occurred in 58% of
patients. Rhabdomyolysis was reported in 0.1% (1 of 690 patients)
with BRAF mutation-positive melanoma receiving MEKTOVI with
BRAFTOVI. Monitor CPK and creatinine levels prior to initiating
MEKTOVI, periodically during treatment, and as clinically
indicated. Withhold, reduce dose, or permanently discontinue based
on severity of adverse reaction.
QTc Prolongation: BRAFTOVI is associated with
dose-dependent QTc interval prolongation in some patients. In the
COLUMBUS trial, an increase in QTcF to > 500 ms was measured in
0.5% (1/192) of patients who received BRAFTOVI in combination with
MEKTOVI. Monitor patients who already have or who are at
significant risk of developing QTc prolongation, including patients
with known long QT syndromes, clinically significant
bradyarrhythmias, severe or uncontrolled heart failure and those
taking other medicinal products associated with QT prolongation.
Correct hypokalemia and hypomagnesemia prior to and during BRAFTOVI
administration. Withhold, reduce dose, or permanently discontinue
for QTc > 500 ms.
Embryo-Fetal Toxicity: BRAFTOVI and MEKTOVI can cause
fetal harm when administered to pregnant women. BRAFTOVI can render
hormonal contraceptives ineffective. Nonhormonal contraceptives
should be used during treatment and for at least 30 days after the
final dose for patients taking BRAFTOVI and MEKTOVI.
Risks Associated with BRAFTOVI as a Single Agent: There
is an increased risk of certain adverse reactions compared to when
BRAFTOVI is used in combination with MEKTOVI. Grades 3 or 4
dermatologic reactions occurred in 21% of patients treated with
BRAFTOVI single agent compared to 2% in patients treated with
BRAFTOVI in combination with MEKTOVI. If MEKTOVI is temporarily
interrupted or permanently discontinued, reduce the dose of
BRAFTOVI as recommended.
ADVERSE REACTIONS
The most common adverse reactions (≥ 20%, all Grades, in the
COLUMBUS trial) for BRAFTOVI and MEKTOVI compared to vemurafenib
were: fatigue (43% vs. 46%, nausea (41% vs. 34%), diarrhea (36% vs.
34%), vomiting (30% vs. 16%), abdominal pain (28% vs. 16%),
arthralgia (26% vs. 46%), myopathy (23% vs. 22%), hyperkeratosis
(23% vs. 49%), rash (22% vs. 53%), headache (22% vs. 20%),
constipation (22% vs. 6%), visual impairment (20% vs. 4%), serous
retinopathy/RFED (20% vs. 2). Other clinically important adverse
reactions occurring in <10% of patients in the COLUMBUS trial
were facial paresis, pancreatitis, panniculitis, drug
hypersensitivity, and colitis.
In the COLUMBUS trial, the most common laboratory abnormalities
(all grades) (≥ 20%) for BRAFTOVI and MEKTOVI compared to
vemurafenib included increased creatinine (93% vs. 92%), increased
creatine phosphokinase (58% vs. 3.8%), increased gamma glutamyl
transferase (GGT) (45% vs. 34%), anemia (36% vs. 34%), increased
ALT (29% vs. 27%), hyperglycemia (28% vs. 20%), increased AST (27%
vs. 24%), and increased alkaline phosphatase (21% vs. 35%).
DRUG INTERACTIONS
Avoid concomitant use of strong or moderate CYP3A4 inhibitors or
inducers and sensitive CYP3A4 substrates with BRAFTOVI. Modify
BRAFTOVI dose if concomitant use of strong or moderate CYP3A4
inhibitors cannot be avoided. Avoid coadministration of BRAFTOVI
with medicinal products with a known potential to prolong QT/QTc
interval.
Please see full U.S. Prescribing Information for BRAFTOVI® and
MEKTOVI® at www.BraftoviMektovi.com.
Pfizer has exclusive rights to BRAFTOVI® and MEKTOVI® in the
U.S. and Canada. Ono Pharmaceutical Co. Ltd. has exclusive rights
to commercialize both products in Japan and South Korea, Medison
has exclusive rights to commercialize both products in Israel and
Pierre Fabre has exclusive rights to commercialize both products in
all other countries, including Europe, Latin American and Asia
(excluding Japan and South Korea).
About Pfizer Oncology
At Pfizer Oncology, we are committed to advancing medicines
wherever we believe we can make a meaningful difference in the
lives of patients. Today, Pfizer Oncology has an industry-leading
portfolio of 22 approved innovative cancer medicines and
biosimilars across more than 30 indications, including breast,
prostate, kidney and lung cancers, as well as leukemia and
melanoma. Pfizer Oncology is striving to change the trajectory of
cancer.
Pfizer Inc.: Breakthroughs that change patients’
lives
At Pfizer, we apply science and our global resources to bring
therapies to people that extend and significantly improve their
lives. We strive to set the standard for quality, safety and value
in the discovery, development and manufacture of health care
products, including innovative medicines and vaccines. Every day,
Pfizer colleagues work across developed and emerging markets to
advance wellness, prevention, treatments and cures that challenge
the most feared diseases of our time. Consistent with our
responsibility as one of the world's premier innovative
biopharmaceutical companies, we collaborate with health care
providers, governments and local communities to support and expand
access to reliable, affordable health care around the world. For
more than 150 years, we have worked to make a difference for all
who rely on us. We routinely post information that may be important
to investors on our website at www.pfizer.com. In addition, to
learn more, please visit us on www.pfizer.com and follow us on
Twitter at @Pfizer and @Pfizer_News, LinkedIn, YouTube and like us
on Facebook at Facebook.com/Pfizer.
DISCLOSURE NOTICE: The information contained in this release is
as of September 19, 2019. Pfizer assumes no obligation to update
forward-looking statements contained in this release as the result
of new information or future events or developments.
This release contains forward-looking information about Pfizer
Oncology’s marketed oncology portfolio, including, among others,
BAVENCIO (avelumab), INLYTA (axitinib), IBRANCE (palbociclib),
LORBRENA (lorlatinib), XTANDI (enzalutamide), BRAFTOVI
(encorafenib) and MEKTOVI (binimetinib) including their potential
benefits, that involves substantial risks and uncertainties that
could cause actual results to differ materially from those
expressed or implied by such statements. Risks and uncertainties
include, among other things, uncertainties regarding the commercial
success of Pfizer’s oncology portfolio; the uncertainties inherent
in research and development, including the ability to meet
anticipated clinical endpoints, commencement and/or completion
dates for our clinical trials, regulatory submission dates,
regulatory approval dates and/or launch dates, as well as the
possibility of unfavorable new clinical data and further analyses
of existing clinical data; the risk that clinical trial data are
subject to differing interpretations and assessments by regulatory
authorities; whether regulatory authorities will be satisfied with
the design of and results from our clinical studies; whether and
when drug applications may be filed in any jurisdictions for any
potential indication for Pfizer’s oncology products and product
candidates; whether and when applications that are pending or any
such other applications that may be filed for any of Pfizer’s
oncology products and product candidates may be approved by
regulatory authorities, which will depend on myriad factors,
including making a determination as to whether the product’s
benefits outweigh its known risks and determination of the
product’s efficacy and, if approved, whether any such oncology
products will be commercially successful; decisions by regulatory
authorities impacting labeling, manufacturing processes, safety
and/or other matters that could affect the availability or
commercial potential of Pfizer’s oncology products and product
candidates; and competitive developments.
A further description of risks and uncertainties can be found in
Pfizer’s Annual Report on Form 10-K for the fiscal year ended
December 31, 2018 and in its subsequent reports on Form 10-Q,
including in the sections thereof captioned “Risk Factors” and
“Forward-Looking Information and Factors That May Affect Future
Results”, as well as in its subsequent reports on Form 8-K, all of
which are filed with the U.S. Securities and Exchange Commission
and available at www.sec.gov and www.pfizer.com.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20190919005400/en/
Pfizer Media Contact: Lisa O’Neill (EU) (44) 7929 339 560
Lisa.O'Neill@pfizer.com
Jessica Smith (US): (212) 733-6213
Jessica.M.Smith@pfizer.com
Pfizer Investor Contact: Ryan Crowe (212) 733-8160
Ryan.Crowe@pfizer.com
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