NORTH CHICAGO, Ill.,
May 30, 2019 /PRNewswire/
-- AbbVie (NYSE: ABBV), a research-based global
biopharmaceutical company, today announced it will present more
than 40 data updates across its oncology portfolio during the
upcoming American Society of Clinical Oncology (ASCO) Annual
Meeting on May 31-June 4, in
Chicago, and the European
Hematology Association (EHA) Annual Congress on June 13-16, in Amsterdam. The data presentations will span
the company's investigational and approved oncology portfolio
medicines in more than 15 different blood and solid tumor
cancers.
For the first time, researchers will also present data from the
Phase 3 CLL14 study evaluating venetoclax (VENCLEXTA®/VENCLYXTO®)
plus obinutuzumab versus obinutuzumab plus chlorambucil at ASCO
(abstract #7502). Results from the trial supported the recent FDA
approval of this VENCLEXTA chemotherapy-free combination for
previously untreated patients with chronic lymphocytic leukemia
(CLL) or small lymphocytic lymphoma (SLL).
Researchers will also present new, multi-year, long-term data on
the use of single-agent ibrutinib (IMBRUVICA®) in CLL/SLL at both
ASCO and EHA in 2019. Six years of follow-up data evaluating
previously treated patients on ibrutinib therapy from the Phase 3
RESONATETM trial (PCYC-1112) will be presented as a
poster discussion at ASCO (abstract #7510), and more than five
years of follow-up for previously untreated patients on ibrutinib
therapy from the Phase 3 RESONATE-2TM trial
(PCYC-1115/1116) will be presented in an oral session at EHA
(abstract #S107). The RESONATETM trial's long-term
follow-up data presentation was also selected to be featured at the
Best of ASCO 2019 Meetings, which highlight cutting-edge science
and reflect the leading research and strategies in oncology.
Following updates earlier this year, the National Comprehensive
Cancer Network® (NCCN®) now recommends ibrutinib (IMBRUVICA®) as a
preferred regimen for the initial treatment of CLL/SLL and the only
Category 1 single-agent regimen for patients without 17p
deletion.1
"The data AbbVie is presenting at ASCO and EHA provide a glimpse
into the progress we are making collaboratively advancing a diverse
pipeline across a broad range of hematologic malignancies and solid
tumors," said Neil Gallagher, M.D.,
Ph.D., vice president, head of global oncology development, AbbVie.
"We continue to make progress with first-in-class medicines like
ibrutinib and venetoclax that are approved and are being further
investigated as potential treatments for several different forms of
hematologic malignancies. AbbVie is also advancing a diverse
oncology portfolio of investigational drugs with the potential to
address unmet needs in other difficult-to-treat cancers."
IMBRUVICA is a once-daily, first-in-class BTK inhibitor that is
administered orally, and is jointly developed and commercialized by
Pharmacyclics LLC, an AbbVie company, and Janssen Biotech, Inc.
VENCLEXTA is a first-in-class BCL-2 inhibitor being developed by
AbbVie and Roche. VENCLEXTA is jointly commercialized by AbbVie and
Genentech, a member of the Roche Group, in the U.S. and by AbbVie
outside of the U.S.
To learn more about our work in oncology, visit
http://www.abbvie.com/oncology.
Presentations include:
Abstract
|
Presentation
Timing
|
ASCO Annual
Meeting
|
Ibrutinib
|
Final Analysis
From RESONATE: 6-Year Follow-up
in Patients (Pts) With Previously Treated Chronic
Lymphocytic Leukemia or Small Lymphocytic
Lymphoma (CLL/SLL) on Ibrutinib; Barr et al.;
Abstract #7510
|
Monday, June
3
Poster Session: 8:00
a.m. - 11:00 a.m. CT
Poster Discussion:
11:30 a.m. - 1:00 p.m. CT
|
Patient-Reported
Outcomes (PROs) With
Ibrutinib-Rituximab in Waldenström
Macroglobulinemia (WM): Results From
iNNOVATE™; Tedeschi et al.; Abstract #8018
|
Monday, June
3
Poster Session: 8:00
a.m. - 11:00 a.m. CT
Poster Discussion:
1:15 p.m. - 2:45 p.m. CT
|
Interim Analysis
of Ibrutinib Plus Paclitaxel for
Patients With Advanced Urothelial Carcinoma
Previously Treated With Platinum-Based
Chemotherapy; Castellano et al.; Abstract #4522
|
Monday, June
3
Poster Session: 1:15
p.m. - 4:15 p.m. CT
|
Venetoclax
|
Effect of
Fixed-Duration Venetoclax Plus
Obinutuzumab (VenG) on Progression-Free
Survival (PFS), and Rates and Duration of Minimal
Residual Disease Negativity (MRD-) in Previously
Untreated Patients (pts) with Chronic
Lymphocytic Leukemia (CLL) and Comorbidities;
Fischer K, et al.; Abstract #7502
|
Tuesday, June
4
Oral Session: 9:45
a.m. - 12:45 p.m. CT
Oral Presentation:
10:09 a.m. - 10:21 a.m. CT
|
Outcomes of
Patients with t(11;14) Multiple
Myeloma: An International Myeloma Working
Group (IMWG) Multicenter Study; Durie BG, et al.;
Abstract #8015
|
Monday, June
3
Poster Session: 8:00
a.m. - 11:00 a.m. CT
Poster Discussion:
1:15 p.m. - 2:45 p.m. CT
|
Randomized Phase 2
Trial of Venetoclax +
Fulvestrant Versus Fulvestrant in Estrogen
Receptor+, HER2- Locally Advanced or Metastatic
Breast Cancer Following Recurrence or
Progression During or After a CDK4/6 Inhibitor:
VERONICA; Lindeman GJ, et al.; Abstract
#TPS1108
|
Sunday, June
2
Poster Session: 8:00
a.m. - 11:00 a.m. CT
|
Veliparib
|
Veliparib in
Combination with
Chemoradiotherapy (CRT) of
Carboplatin/Paclitaxel (C/P) Plus Radiation in
Patients with Stage III Non-Small Cell Lung Cancer
(NSCLC); Kozono DE, et al.; Abstract #8510
|
Sunday, June
2
Poster Session: 8:00
a.m. - 11:00 a.m. CT
Poster Discussion:
11:15 a.m. - 12:45 p.m. CT
|
Mivebresib
|
Results from the
First-in-Human Study of
Mivebresib (ABBV-075), a Pan-Inhibitor of
Bromodomain and Extra Terminal Proteins, in
Patients with Relapsed/Refractory Acute Myeloid
Leukemia; Odenike O, et al.; Abstract #7030
|
Monday, June
3
Poster Session: 8:00
a.m. - 11:00 a.m. CT
|
Cell Free DNA in
Uveal Melanoma: Results from
the First in Human Trial of Mivebresib (ABBV-
075); Patel SP, et al.; Online Publication
|
Online
Publication
|
Depatux-M
|
Phase 1/2 Study of
Depatuxizumab Mafodotin
(ABT-414) Monotherapy or Combination with
Temozolomide in Japanese Patients with/without
EGFR-Amplified Recurrent Glioblastoma; Narita Y,
et al.; Abstract #2065
|
Sunday, June
2
Poster Session: 8:00
a.m. - 11:00 a.m. CT
|
Rova-T
|
Phase 1 Study on
Preliminary Efficacy of
Rovalpituzumab Tesirine in Japanese Patients
with Advanced, Recurrent Small Cell Lung Cancer;
Akamatsu H, et al.; Abstract #8557
|
Sunday, June
2
Poster Session: 8:00
a.m. - 11:00 a.m. CT
|
Ph1/2 Study of
Rova-T in Combination with
Nivolumab (Nivo) ± Ipilimumab (Ipi) for Patients
(Pts) with 2L+ Extensive-Stage (ED) SCLC;
Malhotra J, et al.; Abstract #8516
|
Sunday, June
2
Poster Session: 8:00
a.m. - 11:00 a.m. CT
Poster Discussion:
11:15 a.m. - 12:45 p.m. CT
|
Predictors
Associated with Development of
Pleural and Pericardial Effusions in Patients with
Small Cell Lung Cancer Treated with Third-Line
Therapy; Jiang R, et al.; Online Publication
|
Online
Publication
|
Teslio-V
|
Results of the
Phase 1b Study of ABBV-399
(Telisotuzumab Vedotin; Teliso-V) in Combination
with Erlotinib in Patients with c-Met+ Non-Small Cell
Lung Cancer by EGFR Mutation Status;
Camidge DR, et al.; Abstract #3011
|
Saturday, June
1
Poster Session: 8:00
a.m. - 11:00 a.m. CT
Poster Discussion:
3:00 p.m. - 4:30 p.m. CT
|
c-Met Expression
and Response to Telisotuzumab
Vedotin (Teliso-V) in Patients with Non-Small Cell
Lung Cancer; Heist RS, et al.; Abstract #9023
|
Sunday, June
2
Poster Session: 8:00
a.m. - 11:00 a.m. CT
Poster Discussion:
4:30 p.m. - 6:00 p.m. CT
|
Peripheral
Neuropathy Among Patients with
NSCLC Undergoing Chemotherapy; Tyczynski JE,
et al.; Online Publication
|
Online
Publication
|
ABBV-085
|
First-in-Human
Phase 1 Study of ABBV-085, an
Antibody-Drug Conjugate (ADC) Targeting
LRRC15, in Sarcomas and Other Advanced Solid
Tumors; Demetri GD, et al.; Abstract #3004
|
Monday, June
3
Oral Session: 8:00
a.m. - 11:00 a.m. CT
Oral Presentation:
9:12 a.m. - 9:24 a.m. CT
|
ABBV-621
|
Phase 1,
First-In-Human Study of TRAIL Receptor
Agonist Fusion Protein ABBV-621; Ratain MJ, et
al.; Abstract #3013
|
Saturday, June
1
Poster Session: 8:00
a.m. - 11:00 a.m. CT
Poster Discussion:
3:00 p.m. - 4:30 p.m. CT
|
ABBV-181
|
Safety and
Efficacy of Anti-PD-1 Inhibitor ABBV-
181 in Lung and Head and Neck Carcinoma;
Italiano A, et al.; Online Publication
|
Online
Publication
|
EHA Annual
Congress
|
Ibrutinib
|
Five Year
Follow-Up of Patients Receiving
Ibrutinib for First-Line Treatment of Chronic
Lymphocytic Leukemia; Tedeschi A, et al.;
Abstract #S107
|
Monday, June
14
Oral Session: 11:30
a.m. - 12:45 p.m. CEST
Oral Presentation:
12:00 p.m. - 12:15 p.m. CEST
|
Patient-Reported
Outcomes from the
iNNOVATETM Study: Results of
Ibrutinib-Rituximab
in Waldenström Macroglobulinemia (WM); Tedeschi
A, et al.; Abstract #PF614
|
Monday, June
14
Poster Display: 5:30
p.m. - 7:00 p.m. CEST
|
Prognostic Testing
and Treatment Approaches
Based on Real-World Clinical Experience from an
Interim Analysis of the INFORMCLL Registry of
Patients with Chronic Lymphocytic Leukemia; Mato
AR, et al.; Abstract #PF383
|
Monday, June
14
Poster Display: 5:30
p.m. - 7:00 p.m. CEST
|
Venetoclax
|
A Phase 1b/2
Clinical Study of Targeted IDH1
Inhibition with Ivosidenib in Combination with the
BCL-2 Inhibitor Venetoclax for Patients with IDH1-
mutated (mIDH1) Myeloid Malignancies; DiNardo
CD, et al.; Abstract #PF291
|
Friday, June
14
Poster Session: 5:30
p.m. - 7:00 p.m. CEST
|
Factors Impacting
Treatment Selection in
Treatment-Naïve Patients with CLL: A Multicenter
Study; Rhodes J, et al.; Abstract #PF381
|
Friday, June
14
Poster Session: 5:30
p.m. - 7:00 p.m. CEST
|
Venetoclax for
Chronic Lymphocytic Leukemia: A
Retrospective Chart Review of Safety and Efficacy
From Preapproval Cohort Programs in the
European Union; Schuh, et al.; Abstract #PS1165
|
Saturday, June
15
Poster Session: 5:30
p.m. - 7:00 p.m. CEST
|
Venetoclax Alone
or in Combination with
Rituximab for Japanese Patients with
Relapsed/Refractory Chronic Lymphocytic
Leukemia; Yamamoto K, et al.; Abstract #PB1890
|
Online
Publication
|
Efficacy and
Safety of Ibrutinib in
Relapsed/Refractory Chronic Lymphocytic
Leukemia in Patients Previously Treated with
Venetoclax in the MURANO Study; Greil R, et al.;
Abstract #PS1161
|
Saturday, June
15
Poster Session: 5:30
p.m. - 7:00 p.m. CEST
|
Impact of Major
Genomic Alterations on Outcome
of Relapsed/Refractory (R/R) Chronic Lymphocytic
Leukemia (CLL) Patients (Pts) Treated With
Venetoclax Plus Rituximab (Venr) in the Phase 3
MURANO Study; Wu J, et al.; Abstract #PS1123
|
Saturday, June
15
Poster Session: 5:30
p.m. - 7:00 p.m. CEST
|
Genetic Markers
and Outcome in the CLL14 Trial
of the GCLLSG Comparing Front Line
Obinutuzumab Plus Chlorambucil or Venetoclax in
Patients with Comorbidity; Tausch E, et al.;
Abstract #S105
|
Friday, June
14
Oral Presentation:
11:30 a.m. - 11:45 a.m. CEST
|
Updated Safety and
Efficacy From a Phase 2
Study of Venetoclax Plus Carfilzomib and
Dexamethasone in Patients with
Relapsed/Refractory Multiple Myeloma; Costa LJ,
et al.; Abstract #PS1375
|
Saturday, June
15
Poster Session: 5:30
p.m. - 7:00 p.m. CEST
|
Improved Outcome
in Patients With BCL2-Positive
Diffuse Large B-Cell Lymphoma Treated With
Venetoclax Plus R-Chop: Results From the Phase 2
CAVALLI Study; Morschhauser F, et al.; Abstract
#PF294
|
Friday, June
14
Poster Session: 5:30
p.m. - 7:00 p.m. CEST
|
Mivebresib
|
Results From the
First-In-Human Study of
Mivebresib (Abbv-075), a Pan-Inhibitor of
Bromodomain and Extra Terminal Proteins, in
Patients With Relapsed/Refractory Acute Myeloid
Leukemia; Borthakur G, et al.; Abstract
#PF254
|
Friday, June
14
Poster Session: 5:30
p.m. - 7:00 p.m. CEST
|
Navitoclax
|
Combination BCL-2
Inhibitor Therapy With
Venetoclax (Ven) and Navitoclax (Nav) in Patients
with Relapsed/Refractory (R/R) Acute
Lymphoblastic Leukemia (ALL) and Lymphoblastic
Lymphoma (LL); Pullarkat V, et al.; Abstract
#PS940
|
Saturday, June
15
Poster Session: 5:30
p.m. - 7:00 p.m. CEST
|
Additional
Research
|
Outcomes Of
Patients With t(11;14) Multiple
Myeloma: An International Myeloma Working
Group Multicenter Study; Kumar S, et al.; Abstract
#PF564
|
Friday, June
14
Poster Session: 5:30
p.m. - 7:00 p.m. CEST
|
Longitudinal
Treatment Patterns and Patient
Characteristics Among Individuals Diagnosed
With CLL in Israel; Weil C, et al.; Abstract #PS1166
|
Saturday, June
15
Poster Session: 5:30
p.m. - 7:00 p.m. CEST
|
Patient
Characteristics, Transplant Frequency,
and Treatments in Multiple Myeloma; Karve S, et
al.; Abstract #PF724
|
Friday, June
14
Poster Session: 5:30
p.m. - 7:00 p.m. CEST
|
About VENCLEXTA®/VENCLYXTO®
(venetoclax)
VENCLEXTA®/VENCLYXTO® (venetoclax) is a
first-in-class medicine that selectively binds and inhibits the
B-cell lymphoma-2 (BCL-2) protein. In some blood cancers, BCL-2
prevents cancer cells from undergoing their natural death or
self-destruction process, called apoptosis. VENCLEXTA/VENCLYXTO
targets the BCL-2 protein and works to help restore the process of
apoptosis.2
VENCLEXTA/VENCLYXTO is being developed by AbbVie and Roche. It
is jointly commercialized by AbbVie and Genentech, a member of the
Roche Group, in the U.S. and by AbbVie outside of the U.S.
Together, the companies are committed to BCL-2 research and to
studying venetoclax in clinical trials across several blood and
other cancers.
VENCLEXTA/VENCLYXTO is approved in more than 50 countries,
including the U.S. AbbVie, in collaboration with Roche, is
currently working with regulatory agencies around the world to
bring this medicine to additional eligible patients in need.
Venetoclax is not approved by any regulatory authority, in any
country for the treatment of multiple myeloma.
Uses and Important VENCLEXTA® (venetoclax)
U.S. Safety Information2
Use
VENCLEXTA is a prescription medicine used:
- to treat adults with chronic lymphocytic leukemia (CLL) or
small lymphocytic lymphoma (SLL).
- in combination with azacytidine, or decitabine, or low-dose
cytarabine to treat adults with newly-diagnosed acute myeloid
leukemia (AML) who:
-
- are 75 years of age or older, or
- have other medical conditions that prevent the use of standard
chemotherapy.
It is not known if VENCLEXTA is safe and effective in
children.
What is the most important information I should know about
VENCLEXTA?
VENCLEXTA can cause serious side effects,
including:
Tumor lysis syndrome (TLS). TLS is
caused by the fast breakdown of cancer cells. TLS can cause kidney
failure, the need for dialysis treatment, and may lead to death.
Your healthcare provider will do tests to check your risk of
getting TLS before you start taking VENCLEXTA. You will receive
other medicines before starting and during treatment with VENCLEXTA
to help reduce your risk of TLS. You may also need to receive
intravenous (IV) fluids into your vein. Your healthcare provider
will do blood tests to check for TLS when you first start treatment
and during treatment with VENCLEXTA. It is important to keep your
appointments for blood tests. Tell your healthcare provider right
away if you have any symptoms of TLS during treatment with
VENCLEXTA, including fever, chills, nausea, vomiting, confusion,
shortness of breath, seizures, irregular heartbeat, dark or cloudy
urine, unusual tiredness, or muscle or joint pain.
Drink plenty of water during treatment with VENCLEXTA to help
reduce your risk of getting TLS. Drink 6 to 8 glasses
(about 56 ounces total) of water each day, starting 2 days before
your first dose, on the day of your first dose of VENCLEXTA, and
each time your dose is increased.
Your healthcare provider may delay, decrease your dose, or stop
treatment with VENCLEXTA if you have side effects.
Who should not take VENCLEXTA?
Certain medicines must not be taken when you first start
taking VENCLEXTA and while your dose is being slowly increased
because of the risk of increased TLS.
- Tell your healthcare provider about all the medicines you
take, including prescription and over-the-counter
medicines, vitamins, and herbal supplements. VENCLEXTA and other
medicines may affect each other causing serious side effects.
- Do not start new medicines during treatment with VENCLEXTA
without first talking with your healthcare provider.
Before taking VENCLEXTA, tell your healthcare provider about
all of your medical conditions, including if you:
- have kidney problems.
- have problems with your body salts or electrolytes, such as
potassium, phosphorus, or calcium.
- have a history of high uric acid levels in your blood or
gout.
- are scheduled to receive a vaccine. You should not receive a
"live vaccine" before, during, or after treatment with VENCLEXTA,
until your healthcare provider tells you it is okay. If you are not
sure about the type of immunization or vaccine, ask your healthcare
provider. These vaccines may not be safe or may not work as well
during treatment with VENCLEXTA.
- are pregnant or plan to become pregnant. VENCLEXTA may harm
your unborn baby. If you are able to become pregnant, your
healthcare provider should do a pregnancy test before you start
treatment with VENCLEXTA, and you should use effective birth
control during treatment and for at least 30 days after the last
dose of VENCLEXTA. If you become pregnant or think you are
pregnant, tell your healthcare provider right away.
- are breastfeeding or plan to breastfeed. It is not known if
VENCLEXTA passes into your breast milk. Do not breastfeed during
treatment with VENCLEXTA.
What should I avoid while taking VENCLEXTA?
You should not drink grapefruit juice or eat grapefruit,
Seville oranges (often used in
marmalades), or starfruit while you are taking VENCLEXTA. These
products may increase the amount of VENCLEXTA in your blood.
What are the possible side effects of VENCLEXTA?
VENCLEXTA can cause serious side effects, including:
- Low white blood cell counts (neutropenia). Low
white blood cell counts are common with VENCLEXTA, but can also be
severe. Your healthcare provider will do blood tests to check your
blood counts during treatment with VENCLEXTA.
- Infections. Death and serious infections such as
pneumonia and blood infection (sepsis) have happened during
treatment with VENCLEXTA. Your healthcare provider will closely
monitor and treat you right away if you have a fever or any signs
of infection during treatment with VENCLEXTA.
Tell your healthcare provider right away if you have a fever or
any signs of an infection during treatment with VENCLEXTA.
The most common side effects of VENCLEXTA when used in
combination with obinutuzumab or rituximab or alone in people with
CLL or SLL include low white blood cell counts; low
platelet counts; low red blood cell counts; diarrhea; nausea; upper
respiratory tract infection; cough; muscle and joint pain;
tiredness; and swelling of your arms, legs, hands, and feet.
The most common side effects of VENCLEXTA in combination with
azacitidine or decitabine or low-dose cytarabine in people with AML
include low white blood cell counts; nausea; diarrhea; low
platelet counts; constipation; fever with low white blood cell
counts; low red blood cell counts; infection in blood; rash;
dizziness; low blood pressure; fever; swelling of your arms, legs,
hands, and feet; vomiting; tiredness; shortness of breath;
bleeding; infection in lung; stomach (abdominal) pain; pain in
muscles or back; cough; and sore throat.
VENCLEXTA may cause fertility problems in males. This may affect
your ability to father a child. Talk to your healthcare provider if
you have concerns about fertility.
These are not all the possible side effects of VENCLEXTA. For
more information, ask your healthcare provider or pharmacist.
You are encouraged to report negative side effects of
prescription drugs to the FDA.
Visit http://www.fda.gov/medwatch or call
1-800-FDA-1088.
If you cannot afford your medication,
contact www.pparx.org for assistance.
Please see full Prescribing Information,
including Medication Guide.
Important VENCLYXTO® (venetoclax) EU Safety
Information3
VENCLYXTO
(venetoclax) Indication
Venclyxto in
combination with rituximab is indicated for the treatment of adult
patients with chronic lymphocytic leukaemia(CLL) who have
received at least one prior therapy.
Venclyxto monotherapy is indicated for the treatment
of CLL:
- in the presence of 17p deletion or TP53 mutation in adult
patients who are unsuitable for or have failed a B-cell receptor
pathway inhibitor, or
- in the absence of 17p deletion or TP53 mutation in adult
patients who have failed both chemo immunotherapy and a B-cell
receptor pathway inhibitor.
Contraindications
Hypersensitivity to the active
substance or to any of the excipients is contraindicated.
Concomitant use of strong CYP3A inhibitors at initiation and during
the dose-titration phase due to increased risk for tumor lysis
syndrome (TLS). Concomitant use of preparations containing St.
John's wort as VENCLYXTO efficacy may be reduced.
Special Warnings & Precautions for Use
Tumor lysis
syndrome (TLS), including fatal events, has occurred in patients
with previously treated CLL with high tumor burden when treated
with VENCLYXTO. VENCLYXTO poses a risk for TLS in the initial
5-week dose-titration phase. Changes in electrolytes consistent
with TLS that require prompt management can occur as early as 6 to
8 hours following the first dose of VENCLYXTO and at each dose
increase. Patients should be assessed for risk and should receive
appropriate prophylaxis, monitoring, and management for TLS.
Neutropenia (grade 3 or 4) has been reported and complete blood
counts should be monitored throughout the treatment period. Serious
infections including events of sepsis with fatal outcome have been
reported. Supportive measures including antimicrobials for any
signs of infection should be considered.
Live vaccines should not be administered during treatment or
thereafter until B-cell recovery.
Drug Interactions
CYP3A inhibitors may increase
VENCLYXTO plasma concentrations. At initiation and dose-titration
phase: Strong CYP3A inhibitors are contraindicated due to increased
risk for TLS and moderate CYP3A inhibitors should be avoided. If
moderate CYP3A inhibitors must be used, physicians should refer to
the SmPC for dose adjustment recommendations. At steady daily dose:
If moderate or strong CYP3A inhibitors must be used, physicians
should refer to the SmPC for dose adjustment recommendations.
Avoid concomitant use of P-gp and BCRP inhibitors at initiation
and during the dose titration phase.
CYP3A4 inducers may decrease VENCLYXTO plasma concentrations.
Avoid coadministration with strong or moderate CYP3A inducers.
These agents may decrease venetoclax plasma
concentrations.
Co-administration of bile acid sequestrants with VENCLYXTO is
not recommended as this may reduce the absorption of VENCLYXTO.
Adverse Reactions
The most commonly occurring adverse
reactions (>=20%) of any grade in patients receiving venetoclax
in the combination study with rituximab were neutropenia, diarrhea,
and upper respiratory tract infection. In the monotherapy studies,
the most common adverse reactions were neutropenia/neutrophil count
decreased, diarrhea, nausea, anemia, fatigue, and upper respiratory
tract infection.
The most frequently occurring serious adverse reactions
(>=2%) in patients receiving venetoclax in combination with
rituximab or as monotherapy were pneumonia, febrile neutropenia and
TLS.
Discontinuation due to adverse reactions occurred in 16% of
patients receiving venetoclax plus rituximab and 9% receiving
venetoclax monotherapy. Dosage adjustments due to adverse reactions
occurred in 15% of patients receiving venetoclax plus rituximab and
2% receiving venetoclax monotherapy. Dose interruptions occurred in
71% of patients treated with the combination of venetoclax and
rituximab.
Specific Populations
Patients with reduced renal
function (CrCl <80 mL/min) may require more intensive
prophylaxis and monitoring to reduce the risk of TLS. Safety in
patients with severe renal impairment (CrCl <30 mL/min) or on
dialysis has not been established, and a recommended dose for these
patients has not been determined. VENCLYXTO should be administered
to patients with severe renal impairment only if the benefit
outweighs the risk and patients should be monitored closely for
signs of toxicity due to increased risk of TLS.
VENCLYXTO may cause embryo-fetal harm when administered to a
pregnant woman. Advise nursing women to discontinue breastfeeding
during treatment.
This is not a complete summary of all safety information. See
VENCLYXTO full summary of product characteristics (SmPC) at
www.ema.europa.eu. Globally, prescribing information
varies; refer to the individual country product label for complete
information.
About AbbVie in Oncology
At AbbVie, we strive to discover and develop medicines that
deliver transformational improvements in cancer treatment by
uniquely combining our deep knowledge in core areas of biology with
cutting-edge technologies, and by working together with our
partners – scientists, clinical experts, industry peers, advocates,
and patients. We remain focused on delivering these transformative
advances in treatment across some of the most debilitating and
widespread cancers. We are also committed to exploring solutions to
help patients obtain access to our cancer medicines. With the
acquisitions of Pharmacyclics in 2015 and Stemcentrx in 2016, our
research and development efforts, and through collaborations,
AbbVie's oncology portfolio now consists of marketed medicines and
a pipeline containing multiple new molecules being evaluated
worldwide in more than 200 clinical trials and more than 20
different tumor types. For more information, please visit
http://www.abbvie.com/oncology.
About IMBRUVICA
IMBRUVICA (ibrutinib) is an oral, once-daily medicine that works
differently than chemotherapy, as it blocks a protein called
Bruton's tyrosine kinase (BTK). The BTK protein sends important
signals that tell B cells to mature and produce antibodies. BTK
signaling is needed by specific cancer cells to multiply and
spread.4,5 By blocking BTK, IMBRUVICA may
help move abnormal B cells out of their nourishing environments in
the lymph nodes, bone marrow, and other organs.6
Since its launch in 2013, IMBRUVICA has received 10 FDA
approvals across six disease areas: chronic lymphocytic leukemia
(CLL), small lymphocytic lymphoma (SLL), Waldenström's
macroglobulinemia (WM), previously-treated mantle cell lymphoma
(MCL), previously-treated marginal zone lymphoma (MZL), and
previously-treated chronic graft-versus-host disease
(cGVHD).7 IMBRUVICA is now approved in more than 95
countries and has been used to treat more than 135,000 patients
worldwide across its approved indications.
- IMBRUVICA was first approved for adult patients with MCL who
have received at least one prior therapy in November 2013.*
- Soon after, IMBRUVICA was initially approved in adult CLL
patients who have received at least one prior therapy in
February 2014. By July 2014, the therapy received approval for
adult CLL patients with 17p deletion, and by March 2016, the therapy was approved as a
frontline CLL treatment.
- IMBRUVICA was approved for adult patients with WM in
January 2015.
- In May 2016, IMBRUVICA was
approved in combination with bendamustine and rituximab (BR) for
adult patients with previously treated CLL/SLL.
- In January 2017, IMBRUVICA was
approved for adult patients with MZL who require systemic therapy
and have received at least one prior anti-CD20-based therapy.*
- In August 2017, IMBRUVICA was
approved for adult patients with cGVHD who failed to respond to one
or more lines of systemic therapy.
- In August 2018, IMBRUVICA was
approved in combination with rituximab for adult patients with
WM.
- In January 2019, IMBRUVICA was
approved in combination with obinutuzumab (Gazyva) for previously
untreated adult patients with CLL/SLL.
IMBRUVICA is the only FDA-approved medicine in WM, MZL* and
cGVHD. IMBRUVICA has been granted four Breakthrough Therapy
Designations from the U.S. FDA. This designation is intended to
expedite the development and review of a potential new drug for
serious or life-threatening diseases.8 IMBRUVICA was one
of the first medicines to receive FDA approval via the new
Breakthrough Therapy Designation pathway.
The National Comprehensive Cancer Network® (NCCN®) recommends
ibrutinib (IMBRUVICA®) as a preferred regimen for the initial
treatment of CLL/SLL and the only Category 1 single-agent regimen
for patients without 17p deletion.1
IMBRUVICA is being studied alone and in combination with other
treatments in several blood and solid tumor cancers and other
serious illnesses. IMBRUVICA is an extensively and comprehensively
studied BTK inhibitor, with more than 150 ongoing clinical trials.
There are approximately 30 ongoing company-sponsored trials, 14 of
which are in Phase 3, and more than 100 investigator-sponsored
trials and external collaborations that are active around the
world. For more information, visit www.IMBRUVICA.com.
*Accelerated approval was granted for the MCL and MZL
indications based on overall response rate. Continued approval for
MCL and MZL may be contingent upon verification and description of
clinical benefit in confirmatory trials.
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
Hemorrhage: Fatal bleeding events have occurred in
patients treated with IMBRUVICA®. Grade 3 or
higher bleeding events (intracranial hemorrhage [including subdural
hematoma], gastrointestinal bleeding, hematuria, and post
procedural hemorrhage) have occurred in 3% of patients, with
fatalities occurring in 0.3% of 1,124 patients exposed to
IMBRUVICA® in clinical trials. Bleeding events of
any grade, including bruising and petechiae, occurred in 44% of
patients treated with IMBRUVICA®.
The mechanism for the bleeding events is not well
understood.
IMBRUVICA® may increase the risk of hemorrhage in
patients receiving antiplatelet or anticoagulant therapies and
patients should be monitored for signs of bleeding.
Consider the benefit-risk of withholding IMBRUVICA®
for at least 3 to 7 days pre- and post-surgery depending upon the
type of surgery and the risk of bleeding.
Infections: Fatal and non-fatal infections (including
bacterial, viral, or fungal) have occurred with
IMBRUVICA® therapy. Grade 3 or greater infections
occurred in 24% of 1,124 patients exposed to IMBRUVICA®
in clinical trials. Cases of progressive multifocal
leukoencephalopathy (PML) and Pneumocystis jirovecii
pneumonia (PJP) have occurred in patients treated with
IMBRUVICA®. Consider prophylaxis according to standard
of care in patients who are at increased risk for opportunistic
infections.
Monitor and evaluate patients for fever and infections and treat
appropriately.
Cytopenias: Treatment-emergent Grade 3 or 4 cytopenias
including neutropenia (23%), thrombocytopenia (8%), and anemia (3%)
based on laboratory measurements occurred in patients with B‑cell
malignancies treated with single agent IMBRUVICA®.
Monitor complete blood counts monthly.
Cardiac Arrhythmias: Fatal and serious cardiac
arrhythmias have occurred with IMBRUVICA® therapy.
Grade 3 or greater ventricular tachyarrhythmias occurred in 0.2% of
patients, and Grade 3 or greater atrial fibrillation and atrial
flutter occurred in 4% of 1,124 patients exposed to
IMBRUVICA® in clinical trials. These events have
occurred particularly in patients with cardiac risk factors,
hypertension, acute infections, and a previous history of cardiac
arrhythmias.
Periodically monitor patients clinically for cardiac
arrhythmias. Obtain an ECG for patients who develop arrhythmic
symptoms (e.g., palpitations, lightheadedness, syncope, chest pain)
or new onset dyspnea. Manage cardiac arrhythmias appropriately, and
if it persists, consider the risks and benefits of
IMBRUVICA® treatment and follow dose modification
guidelines.
Hypertension: Hypertension of any grade occurred in 12%
of 1,124 patients treated with IMBRUVICA® in clinical
trials. Grade 3 or greater hypertension occurred in 5% of patients
with a median time to onset of 5.9 months (range, 0.03 to 24
months).
Monitor blood pressure in patients treated with
IMBRUVICA® and initiate or adjust anti-hypertensive
medication throughout treatment with IMBRUVICA® as
appropriate.
Second Primary Malignancies: Other malignancies (10%)
including non-skin carcinomas (4%) have occurred in 1,124 patients
treated with IMBRUVICA® in clinical trials. The most
frequent second primary malignancy was non-melanoma skin cancer
(6%).
Tumor Lysis Syndrome: Tumor lysis syndrome has been
infrequently reported with IMBRUVICA® therapy. Assess
the baseline risk (e.g., high tumor burden) and take appropriate
precautions.
Monitor patients closely and treat as appropriate.
Embryo-Fetal Toxicity: Based on findings in animals,
IMBRUVICA® can cause fetal harm when administered to a
pregnant woman. Advise women to avoid becoming pregnant while
taking IMBRUVICA® and for 1 month after cessation of
therapy. If this drug is used during pregnancy or if the patient
becomes pregnant while taking this drug, the patient should be
apprised of the potential hazard to a fetus. Advise men to avoid
fathering a child during the same time period.
ADVERSE REACTIONS
B-cell malignancies: The most common adverse
reactions (≥20%) in patients with B-cell malignancies (MCL,
CLL/SLL, WM and MZL) were thrombocytopenia (58%)*, diarrhea (41%),
anemia (38%)*, neutropenia (35%)*, musculoskeletal pain (32%), rash
(32%), bruising (31%), nausea (26%), fatigue (26%), hemorrhage
(24%), and pyrexia (20%).
The most common Grade 3 or 4 adverse reactions (≥5%) in patients
with B-cell malignancies (MCL, CLL/SLL, WM and MZL) were
neutropenia (18%)*, thrombocytopenia (16%)*, and pneumonia
(14%).
Approximately 7% (CLL/SLL),
14% (MCL), 14% (WM)
and 10% (MZL) of patients had a
dose reduction due to adverse reactions.
Approximately 4-10% (CLL/SLL), 9% (MCL), and
7% (WM [5%] and MZL [13%]) of patients
discontinued due to adverse reactions.
cGVHD: The most common adverse reactions (≥20%) in patients with cGVHD were fatigue (57%),
bruising (40%), diarrhea (36%), thrombocytopenia (33%)*, muscle spasms (29%),
stomatitis (29%), nausea (26%),
hemorrhage (26%), anemia (24%)*, and pneumonia
(21%).
The most common Grade 3 or higher adverse reactions (≥5%) reported in patients with cGVHD were
pneumonia (14%), fatigue (12%), diarrhea (10%),
neutropenia (10%)*, sepsis (10%), hypokalemia (7%),
headache (5%), musculoskeletal pain (5%), and pyrexia
(5%).
Twenty-four percent of patients receiving IMBRUVICA® in the
cGVHD trial discontinued treatment due to adverse reactions.
Adverse reactions leading to dose reduction occurred in 26% of
patients.
*Treatment-emergent decreases (all grades) were based on
laboratory measurements.
DRUG INTERACTIONS
CYP3A Inhibitors: Modify IMBRUVICA®
dose as described in USPI sections 2.4 and 7.1.
CYP3A Inducers: Avoid coadministration with
strong CYP3A inducers.
SPECIFIC POPULATIONS
Hepatic Impairment (based on Child-Pugh
criteria): Avoid use of
IMBRUVICA®
in patients with severe baseline hepatic
impairment. In patients with mild or moderate impairment,
reduce IMBRUVICA® dose.
Please click here for full Prescribing Information.
About AbbVie
AbbVie is a global, research and development-based
biopharmaceutical company committed to developing innovative
advanced therapies for some of the world's most complex and
critical conditions. The company's mission is to use its expertise,
dedicated people and unique approach to innovation to markedly
improve treatments across four primary therapeutic areas:
immunology, oncology, virology and neuroscience. In more than
75 countries, AbbVie employees are working every day to advance
health solutions for people around the world. For more information
about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on
Twitter, Facebook, LinkedIn or Instagram.
Forward-Looking Statements
Some statements in this news release are, or may be considered,
forward-looking statements for purposes of the Private Securities
Litigation Reform Act of 1995. The words "believe," "expect,"
"anticipate," "project" and similar expressions, among others,
generally identify forward-looking statements. AbbVie cautions that
these forward-looking statements are subject to risks and
uncertainties that may cause actual results to differ materially
from those indicated in the forward-looking statements. Such risks
and uncertainties include, but are not limited to, competition from
other products, challenges to intellectual property, difficulties
inherent in the research and development process, adverse
litigation or government action, and changes to laws and
regulations applicable to our industry. Additional information
about the economic, competitive, governmental, technological and
other factors that may affect AbbVie's operations is set forth in
Item 1A, "Risk Factors," of AbbVie's 2018 Annual Report on Form
10-K, which has been filed with the Securities and Exchange
Commission. AbbVie undertakes no obligation to release publicly any
revisions to forward-looking statements as a result of subsequent
events or developments, except as required by law.
1 National Comprehensive Cancer Network Clinical
Practice Guidelines in Oncology. Chronic Lymphocytic Leukemia/Small
Lymphocytic Lymphoma. May 2019.
https://www.nccn.org/professionals/physician_gls/pdf/cll.pdf.
Accessed May 2019.
2 VENCLEXTA (venetoclax) [Package Insert]. North Chicago, IL.: AbbVie Inc.
3 Summary of Product Characteristics for VENCLYXTO
(venetoclax). Ludwigshafen, Germany: AbbVie Deutschland GmbH & Co.
KG.
4 Genetics Home Reference. Isolated growth hormone
deficiency.
http://ghr.nlm.nih.gov/condition/isolated-growth-hormone-deficiency.
Accessed January 2019.
5 Turetsky, et al. Single cell imaging of Bruton's
Tyrosine Kinase using an irreversible inhibitor. Scientific
Reports. volume 4, Article number: 4782 (2014).
6 de Rooij MF, Kuil A, Geest CR, et al. The clinically
active BTK inhibitor PCI-32765 targets B-cell receptor- and
chemokine-controlled adhesion and migration in chronic lymphocytic
leukemia. Blood. 2012;119(11):2590-2594.
7 IMBRUVICA U.S. Prescribing Information, January 2019
8 U.S. Food and Drug Administration. Fact sheet:
breakthrough therapies.
https://www.fda.gov/RegulatoryInformation/LawsEnforcedbyFDA/SignificantAmendmentstotheFDCAct/FDASIA/ucm329491.htm.
Accessed June 2018.
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