Approval of expanded indication based
predominately on real-world data
Pfizer (NYSE:PFE) today announced that the U.S. Food and Drug
Administration (FDA) approved a supplemental New Drug Application
(sNDA) to expand the indications for IBRANCE® (palbociclib) in
combination with an aromatase inhibitor or fulvestrant to include
men with hormone receptor-positive (HR+), human epidermal growth
factor receptor 2-negative (HER2-) advanced or metastatic breast
cancer. The approval is based on data from electronic health
records and postmarketing reports of the real-world use of IBRANCE
in male patients sourced from three databases: IQVIA Insurance
database, Flatiron Health Breast Cancer database and the Pfizer
global safety database.
“With this approval, we are now able to offer IBRANCE to the
underserved male breast cancer community and provide more patients
with HR+, HER2- metastatic breast cancer the opportunity to access
an innovative medicine,” said Chris Boshoff, M.D., Ph.D., Chief
Development Officer, Oncology, Pfizer Global Product Development.
“We appreciate that our partnership with the FDA has allowed us to
take a significant step forward in the use of real-world data to
bring medicines to patients who are most in need.”
IBRANCE is now approved for 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 with fulvestrant in patients
with disease progression following endocrine therapy. With today’s
approval, IBRANCE is the first and only CDK 4/6 inhibitor indicated
in combination with an aromatase inhibitor for the first-line
treatment of men with HR+, HER2- metastatic breast cancer in the
U.S.
“Men with breast cancer have limited treatment options, making
access to medicines such as IBRANCE critically important,” said
Bret Miller, founder of the Male Breast Cancer Coalition. “We
applaud the use of real-world data, a new approach to drug review,
to make IBRANCE available to certain men with metastatic breast
cancer and help address an unmet need for these patients.”
Real-world data is playing an increasingly important role in
expanding the use of already approved innovative medicines.1 Due to
the rarity of breast cancer in males, fewer clinical trials are
conducted that include men resulting in fewer approved treatment
options. In the U.S. in 2019, it is estimated that there will be
2,670 new cases of invasive breast cancer and about 500 deaths from
metastatic breast cancer in males.2 The 21st Century Cures Act,
enacted in 2016, was created to help accelerate medical product
development, allowing new innovations and advances to become
available to patients who need them faster and more efficiently.3
This law places additional focus on the use of real-world data to
support regulatory decision-making.4
Detailed analysis of the use of IBRANCE in men with HR+, HER2-
advanced or metastatic breast cancer will be presented at an
upcoming medical meeting. Based on limited data from postmarketing
reports and electronic health records, the safety profile for men
treated with IBRANCE is consistent with the safety profile in women
treated with IBRANCE.5
About IBRANCE® (palbociclib) 125 mg
capsules
IBRANCE is an oral inhibitor of CDKs 4 and 6,6 which are
key regulators of the cell cycle that trigger cellular
progression.7,8 In the U.S., IBRANCE is indicated for the treatment
of adult patients with hormone receptor-positive (HR+), human
epidermal growth factor receptor 2-negative (HER2-) advanced or
metastatic breast cancer in combination with an aromatase inhibitor
as initial endocrine based therapy in postmenopausal women or in
men; or with fulvestrant in patients with disease progression
following endocrine therapy.
IBRANCE currently is approved in more than 90 countries and has
been prescribed to more than 200,000 patients globally.
The full prescribing information for IBRANCE can be found
here.
IMPORTANT IBRANCE® (palbociclib) SAFETY
INFORMATION FROM THE U.S. PRESCRIBING INFORMATION
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.
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.
About Pfizer Oncology
At Pfizer Oncology, we are committed to advancing medicines
wherever we believe we can make a meaningful difference on the
lives of patients. Today, Pfizer Oncology has an industry-leading
portfolio of 18 approved innovative cancer medicines and
biosimilars across more than 20 indications, including breast,
prostate, kidney, lung and hematology. Pfizer Oncology is striving
to change the trajectory of cancer.
Working together for a healthier world®
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. Our global portfolio includes medicines and vaccines as
well as many of the world's best-known consumer health care
products. 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
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addition, to learn more, please visit us on www.pfizer.com and
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DISCLOSURE NOTICE: The information contained in this release is
as of April 4, 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 the
expansion of the indication for IBRANCE (palbociclib) in
combination with an aromatase inhibitor or fulvestrant to include
men with hormone receptor-positive (HR+), human epidermal growth
factor receptor 2-negative (HER2-) advanced or metastatic breast
cancer and Pfizer Oncology, 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 IBRANCE;
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 any drug applications may be filed in any other
jurisdictions for IBRANCE, for any additional indications for
IBRANCE or for any other oncology products; whether and when any
such applications 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
IBRANCE or any such other oncology products will be commercially
successful; decisions by regulatory authorities impacting labeling,
safety, manufacturing processes and/or other matters that could
affect the availability or commercial potential of IBRANCE or any
other oncology products; 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.
_______________________________1 FDA: Real World Evidence.
https://www.fda.gov/scienceresearch/specialtopics/realworldevidence/default.htm.
Accessed March 5, 2019.2 American Cancer Society. Key statistics
for breast cancer in men.
https://www.cancer.org/cancer/breast-cancer-in-men/about/key-statistics.html.
Accessed March 20, 2019.3 FDA: 21st Century Cures Act.
https://www.fda.gov/regulatoryinformation/lawsenforcedbyfda/significantamendmentstothefdcact/21stcenturycuresact/default.htm.
Accessed March 5, 2019.4 FDA: Real World Evidence.
https://www.fda.gov/ScienceResearch/SpecialTopics/RealWorldEvidence/default.htm.
Accessed March 5, 2019.5 Pfizer global safety database.6 IBRANCE®
(palbociclib) Prescribing Information. New York. NY: Pfizer Inc:
2019.7 Weinberg, RA. pRb and Control of the Cell Cycle Clock. In:
Weinberg RA, ed. The Biology of Cancer. 2nd ed. New York, NY:
Garland Science; 2014:275-329.8 Sotillo E, Grana X. Escape from
Cellular Quiescence. In: Enders GH, ed. Cell Cycle Deregulation in
Cancer. New York, NY: Humana Press; 2010:3-22.
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version on businesswire.com: https://www.businesswire.com/news/home/20190404005732/en/
Pfizer Media:Jessica
Smith212-733-6213Jessica.M.Smith@pfizer.com
Pfizer Investors:Ryan Crowe212-733-8160Ryan.Crowe@pfizer.com
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