NORTH CHICAGO, Ill.,
Nov. 21, 2019 /PRNewswire/ -- AbbVie
(NYSE: ABBV), a research-based global biopharmaceutical company,
today announced that more than 40 abstracts, including 18 oral
presentations, will be presented during the upcoming American
Society of Hematology (ASH) Annual Meeting & Exposition,
December 7-10, in Orlando, FL. New data include presentations on
Ibrutinib (IMBRUVICA®) plus venetoclax
(VENCLEXTA®/ VENCLYXTO®) among others.
"At this year's ASH Annual Meeting, AbbVie will showcase the
latest scientific progress from our portfolio spanning various
hematologic malignancies," said Mohamed
Zaki, M.D., Ph.D., Head of Hematology Oncology, AbbVie. "We
look forward to sharing the new data from our clinical development
programs for ibrutinib and venetoclax, which continue to
demonstrate the potential to transform care and improve the lives
of people living with various difficult-to-treat blood
cancers."
Data from two studies of ibrutinib combination regimens in the
first-line treatment of chronic lymphocytic leukemia/small
lymphocytic lymphoma (CLL/SLL) will be featured in the CLL Therapy
Oral Session. A new minimal residual disease (MRD)-guided analysis
from the Phase 2 CAPTIVATE study (PCYC-1142) of ibrutinib in
combination with venetoclax will be presented (Abstract #35), as
well as longer-term outcomes data from the Phase 3 E1912 study of
ibrutinib in combination with rituximab, which served as the basis
of a recent U.S. Food and Drug Administration (FDA) sNDA submission
(Abstract #33). In addition, extended follow-up data of up to 7.5
years in patients with relapsed or refractory (R/R) mantle cell
lymphoma (MCL) supporting the long-term disease control and
tolerability with ibrutinib (Abstract #1538) and a four-year
updated analysis from the Phase 3 MURANO trial of venetoclax in
combination with rituximab will be shared (Abstract #355).
These new data will provide insights on the ongoing evaluation
of ibrutinib (IMBRUVICA®) and venetoclax
(VENCLEXTA/VENCLYXTO®) use among a variety of CLL
patients.
Details about presentations are as follows:
Abstract
|
Presentation
Timing
|
Ibrutinib
|
Ibrutinib Plus
Venetoclax for First-line Treatment of
CLL/SLL: Results from the MRD Cohort of Phase 2
CAPTIVATE Study (PCYC-1142); Tam et al.;
Abstract #35
|
Saturday, December
7
Oral Session: 7:30
a.m. – 9:00 a.m. ET
Oral Presentation:
8:30 a.m. ET
|
Ibrutinib and
Rituximab Compared to FCR in
Younger Patients with CLL: Extended Follow-Up
from the E1912 Trial; Shanafelt et al.; Abstract #33*
|
Saturday, December
7
Oral Session: 7:30
a.m. – 9:00 a.m. ET
Oral Presentation:
8:00 a.m. ET
|
Long-Term Outcomes
with Ibrutinib Versus the Prior
Regimen: A Pooled Analysis in Relapsed/Refractory
MCL with up to 7.5 Years of Extended Follow-up
(MCL2001, MCL3001, CAN3001, PCYC-1104); Rule
et al.; Abstract #1538
|
Saturday, December
7
Poster Session: 5:30
p.m. – 7:30 p.m. ET
|
Planned Analysis of
the Phase 1/2 CIRLL Trial for
CLL and MCL of Cirmtuzumab in Combination with
Ibrutinib; Choi et al.; Abstract #1755
|
Saturday, December
7
Poster Session: 5:30
p.m. – 7:30 p.m. ET
|
Clinical Impact of
Ibrutinib with R-CHOP in Untreated
Non-GCB DLBCL Co-Expressing BCL2 and MYC
Genes in the Phase 3 PHOENIX Trial; Johnson et al.;
Abstract #354**
|
Sunday, December
8
Oral Session: 7:30
a.m. – 9:00 a.m. ET
Oral Presentation:
8:45 a.m. ET
|
Using Ibrutinib in
Earlier Lines of Treatment in
CLL/SLL (RESONATE/RESONATE-2); Barr et al.;
Abstract #3054
|
Sunday, December
8
Poster Session: 6:00
p.m. – 8:00 p.m. ET
|
Phase 2 Results of
the iR2 Regimen (Ibrutinib,
Lenalidomide, and Rituximab) in Patients with
Relapsed/Refractory Non-germinal Center B Cell–
Like (Non-GCB) Diffuse Large B-Cell Lymphoma
(DLBCL) (PCYC-1123); Ramchandren et al.;
Abstract #761
|
Monday, December
9
Oral Session: 2:45
p.m. – 4:15 p.m. ET
Oral Presentation:
3:45 p.m. ET
|
Venetoclax
|
Ibrutinib (Ibr) Plus
Venetoclax (Ven) for First-Line
Treatment of Chronic Lymphocytic Leukemia
(CLL)/Small Lymphocytic Lymphoma (SLL): Results
from the MRD Cohort of the Phase 2 CAPTIVATE
Study
|
Saturday, December
7
Oral Session: 7:30
a.m. – 9:00 a.m. ET
Oral Presentation:
8:30 a.m. ET
|
Quantitative Analysis
of Minimal Residual Disease
(MRD) Shows High Rates of Undetectable MRD
After Fixed-Duration Chemotherapy-Free Treatment
and Serves as Surrogate Marker for Progression-
Free Survival: A Prospective Analysis of the
Randomized CLL14 trial
|
Saturday, December
7
Oral Session: 7:30
a.m. – 9:00 a.m. ET
Oral Presentation:
8:45 a.m. ET
|
T(11;14) and High
BCL2 Expression are Predictive
Biomarkers of Response to Venetoclax in
Combination with Bortezomib and Dexamethasone
in Patients with Relapsed/Refractory Multiple
Myeloma: Biomarker Analyses from the Phase 3
BELLINI Study
|
Saturday, December
7
Oral Session: 9:30
a.m. – 11:00 a.m. ET
Oral Presentation:
10:15 a.m. ET
|
Identification of
Recurrent Genomic Alterations in the
Apoptotic Machinery in CLL Patients Treated with
Venetoclax Monotherapy
|
Saturday, December
7
Oral Session: 12:00
p.m. – 1:30 p.m. ET
Oral Presentation:
12:45 p.m. ET
|
Updated Results from
the Venetoclax (Ven) in
Combination with Idasanutlin (Idasa) Arm of a Phase
1b Trial in Elderly Patients (Pts) with Relapsed or
Refractory (R/R) Acute Myeloid Leukemia (AML)
Ineligible for Cytotoxic Chemotherapy
|
Saturday, December
7
Oral Session: 2:00
p.m. – 3:30 p.m. ET
Oral Presentation:
2:00 p.m. ET
|
Outcomes After Stem
Cell Transplant in Older
Patients with Acute Myeloid Leukemia Treated with
Venetoclax-Based Therapies
|
Saturday, December
7
Oral Session: 2:00
p.m. – 3:30 p.m. ET
Oral Presentation:
3:15 p.m. ET
|
Safety and Efficacy
of Venetoclax in Combination
with Navitoclax in Adult and Pediatric
Relapsed/Refractory Acute Lymphoblastic Leukemia
and Lymphoblastic Lymphoma
|
Saturday, December
7
Oral Session: 4:00
p.m. – 5:30 p.m. ET
Oral Presentation:
4:30 p.m. ET
|
Four-Year Analysis of
MURANO Study Confirms
Sustained Benefit of Time-Limited Venetoclax-
Rituximab (VenR) in Relapsed/Refractory (R/R)
Chronic Lymphocytic Leukemia (CLL)
|
Sunday, December
8
Oral Session: 7:30
a.m. – 9:00 a.m. ET
Oral Presentation:
7:30 a.m. ET
|
Genome and Exome-Wide
Studies Reveal Potential
Predictive Efficacy Markers for Venetoclax and
Rituximab (VenR) in Relapsed/Refractory Chronic
Lymphocytic Leukemia (R/R CLL): Subgroup
Analyses of the MURANO Trial
|
Sunday, December
8
Oral Session: 7:30
a.m. – 9:00 a.m. ET
Oral Presentation:
7:45 a.m. ET
|
A Phase 1b Study
Evaluating the Safety and Efficacy
of Venetoclax as Monotherapy or in Combination
with Azacitidine for the Treatment of
Relapsed/Refractory Myelodysplastic Syndrome
|
Monday, December
9
Oral Session: 7:00
a.m. – 8:30 a.m. ET
Oral Presentation:
7:00 a.m. ET
|
A Phase 1b Study
Evaluating the Safety and Efficacy
of Venetoclax in Combination with Azacitidine in
Treatment-Naïve Patients with Higher-Risk
Myelodysplastic Syndrome
|
Monday, December
9
Oral Session: 7:00
a.m. – 8:30 a.m. ET
Oral Presentation:
7:45 a.m. ET
|
Biomarker Modulation
by Mivebresib (ABBV-075) +/–
Venetoclax in Relapsed/Refractory Acute Myeloid
Leukemia
|
Monday, December
9
Oral Session: 7:00
a.m. – 8:30 a.m. ET
Oral Presentation:
8:00 a.m. ET
|
Response to
Venetoclax in Combination with Low
Intensity Therapy (LDAC or HMA) in Untreated
Patients with Acute Myeloid Leukemia Patients with
IDH, FLT3 and Other Mutations and Correlations
with BCL2 Family Expression
|
Monday, December
9
Oral Session: 7:00
a.m. – 8:30 a.m. ET
Oral Presentation:
8:15 a.m. ET
|
First Analysis from a
Phase 1/2 Study of Venetoclax
in Combination with Daratumumab and
Dexamethasone, +/- Bortezomib, in Patients with
Relapsed/Refractory Multiple Myeloma
|
Monday, December
9
Oral Session: 6:15
p.m. – 7:45 p.m. ET
Oral Presentation:
6:15 p.m. ET
|
Phase 1/2 Study
Evaluating the Safety and Efficacy
of Venetoclax in Combination with Dexamethasone
as Targeted Therapy for Patients with t(11;14)
Relapsed/Refractory Multiple Myeloma
|
Monday, December
9
Oral Session: 6:15
p.m. – 7:45 p.m. ET
Oral Presentation:
6:30 p.m. ET
|
Navitoclax
|
Results from a Phase
2 Study of Navitoclax in
Combination with Ruxolitinib in Patients with Primary
or Secondary Myelofibrosis
|
Monday, December
9
Oral Session: 10:30
a.m. – 12:00 p.m. ET
Oral Presentation:
11:30 a.m. ET
|
|
*Abstract was
submitted by the National Cancer Institute
|
**Abstract was
submitted by IMBRUVICA co-development partner, Janssen Biotech,
Inc.
|
About Ibrutinib (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 multiple and
spread.1,2 By blocking BTK, IMBRUVICA may
help move abnormal B cells out of their nourishing environments in
the lymph nodes, bone marrow, and other organs.3
IMBRUVICA is jointly developed and commercialized by
Pharmacyclics LLC, an AbbVie company, and Janssen Biotech, Inc.
Since its launch in 2013, IMBRUVICA has received 10 FDA approvals
across six disease areas: chronic lymphocytic leukemia (CLL)
with or without 17p deletion (del17p); small lymphocytic lymphoma
(SLL) with or without del17p; Waldenström's macroglobulinemia (WM);
previously-treated patients with mantle cell lymphoma (MCL)*;
previously-treated patients with marginal zone lymphoma (MZL) who
require systemic therapy and have received at least one prior
anti-CD20-based therapy* – and previously-treated patients with
chronic graft-versus-host disease (cGVHD) after failure of one or
more lines of systemic therapy.4
IMBRUVICA is now approved in 95 countries and has been used to
treat more than 170,000 patients worldwide across its approved
indications. IMBRUVICA is the only FDA-approved medicine in WM 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. IMBRUVICA was one of the
first medicines to receive FDA approval via the Breakthrough
Therapy Designation pathway.
The NCCN Clinical Practice Guidelines in Oncology (NCCN
Guidelines®) for CLL recommends ibrutinib (IMBRUVICA®) as a
preferred regimen for the initial treatment of CLL/SLL and it is
the only Category 1 single-agent regimen for treatment-naïve
patients without deletion 17p.
IMBRUVICA is being studied alone and in combination with other
treatments in several blood and solid tumor cancers and other
serious illnesses. IMBRUVICA is the most 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®. Major hemorrhage
(≥ Grade 3, serious, or any central nervous system events;
e.g., intracranial hemorrhage [including subdural hematoma],
gastrointestinal bleeding, hematuria, and post procedural
hemorrhage) have occurred in 4% of patients, with fatalities
occurring in 0.4% of 2,838 patients exposed to
IMBRUVICA® in 27 clinical trials. Bleeding events
of any grade, including bruising and petechiae, occurred in 39% of
patients treated with IMBRUVICA®.
The mechanism for the bleeding events is not well
understood.
Use of either anticoagulant or antiplatelet agents concomitantly
with IMBRUVICA® increases the risk of major hemorrhage.
In IMBRUVICA® clinical trials, 3.1% of patients taking
IMBRUVICA® without antiplatelet or anticoagulant therapy
experienced major hemorrhage. The addition of antiplatelet
therapy with or without anticoagulant therapy increased this
percentage to 4.4%, and the addition of anticoagulant therapy with
or without antiplatelet therapy increased this percentage to 6.1%.
Consider the risks and benefits of anticoagulant or antiplatelet
therapy when co-administered with IMBRUVICA®. Monitor
for signs and symptoms 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: Co-administration of
IMBRUVICA® with strong or moderate CYP3A inhibitors may
increase ibrutinib plasma concentrations. Dose modifications of
IMBRUVICA® may be recommended when used concomitantly
with posaconazole, voriconazole, and moderate CYP3A inhibitors.
Avoid concomitant use of other strong CYP3A inhibitors. Interrupt
IMBRUVICA® if strong inhibitors are used short-term
(e.g., for ≤ 7 days). See dose modification guidelines 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 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.
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.
Uses and Important VENCLEXTA® (venetoclax)
U.S. Safety Information5
Uses
VENCLEXTA is a prescription medicine used:
- to treat adults with chronic lymphocytic leukemia (CLL) or
small lymphocytic lymphoma (SLL).
- in combination with azacitidine, 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.
VENCLEXTA was approved based on response rates. Continued approval
for this use may depend on the results of an ongoing study to find
out how VENCLEXTA works over a longer period of time.
It is not known if VENCLEXTA is safe and effective in
children.
Important Safety Information
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 or liver 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 www.fda.gov/medwatch or call 1-800-FDA-1088.
If you cannot afford your medication, contact
www.medicineassistancetool.org for assistance.
The full U.S. prescribing information, including Medication
Guide, for VENCLEXTA can be found here.
Indication and Important VENCLYXTO (venetoclax) EU Safety
Information6
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 chemoimmunotherapy 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. For patients with severe
(Child-Pugh C) hepatic impairment, a dose reduction of at
least 50% throughout treatment is recommended.
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. AbbVie's
oncology portfolio now consists of marketed medicines and a
pipeline containing multiple new molecules being evaluated
worldwide in more than 300 clinical trials and more than 20
different tumor types. For more information, please visit
http://www.abbvie.com/oncology.
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.
IMBRUVICA is a registered trademark of Pharmacyclics LLC.
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Accessed October 2019.
2 Turetsky, et al. Single cell imaging of Bruton's
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3 de Rooij MF, Kuil A, Geest CR, et al. The
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4 IMBRUVICA U.S. Prescribing
Information, September 2019.
5 VENCLEXTA (venetoclax) [Package Insert].
North Chicago, IL.: AbbVie
Inc.
6 Summary of Product Characteristics for VENCLYXTO
(venetoclax). Ludwigshafen, Germany: AbbVie Deutschland GmbH
& Co. KG.
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