NORTH CHICAGO, Ill.,
May 19, 2021 /PRNewswire/
-- AbbVie (NYSE: ABBV) will present results from
43 abstracts across 12 types of cancer during the upcoming
virtual American Society of Clinical Oncology (ASCO) Annual Meeting
(June 4-8) and the virtual European
Hematology Association (EHA) congress (June
9-17).
"We are advancing discovery and innovation to improve on the
standards of care for blood cancer treatment," said Mohamed Zaki, M.D., Ph.D., vice president and
global head of oncology development, AbbVie. "We look forward to
showcasing research from our expanding oncology portfolio at the
ASCO 2021 annual meeting and EHA 2021 congress."
Presentations include nine oral presentations (two at ASCO and
seven at EHA) and 32 poster presentations (13 at ASCO and 19 at
EHA).
At ASCO, AbbVie will present data from its Phase 2 CAPTIVATE
study evaluating complete response (CR) and progression-free
survival (PFS) among other study metrics in previously untreated
patients with chronic lymphocytic leukemia (CLL)/small lymphocytic
leukemia (SLL) who received an ibrutinib (IMBRUVICA®) +
venetoclax (VENCLEXTA®/VENCLYXTO®)
combination regimen.
In addition, during the congresses, AbbVie will present results
from several studies, including those that evaluate venetoclax in
several combination regimens and in multiple hematological
malignancies. These include a four-year follow-up of the CLL14
trial of venetoclax plus obinutuzumab in patients with previously
untreated CLL, long-term results from the MURANO trial of
venetoclax plus rituximab in relapsed/refractory CLL, and
additional post-hoc analyses of the VIALE-A trial of venetoclax in
combination with azacitidine in patients with acute myeloid
leukemia (AML). An up-to seven-year follow up of the ibrutinib
RESONATE-2 study in first-line CLL will also be presented and add
to robust long-term efficacy and safety data for this therapy.
Details about presentations are as follows:
ASCO 2021
Abstracts
|
Abstract
|
Presentation
Details
All Times in
CT
|
Ibrutinib
|
Up to Seven Years of
Follow-up in the
RESONATE-2 Study of First-line Ibrutinib
Treatment for Patients with Chronic L
ymphocytic Leukemia (CLL)
|
Session: Hematologic
Malignancies—Lymphoma and Chronic Lymphocytic Leukemia
Friday, June
4
8:00 a.m.
(CT)
Poster
Discussion
|
Phase 1/2 Study of
Cirmtuzumab and
Ibrutinib in Mantle Cell Lymphoma (MCL) or
Chronic Lymphocytic Leukemia (CLL)
|
Session: Hematologic
Malignancies—Lymphoma and Chronic Lymphocytic Leukemia
Friday, June
4
8:00 a.m.
(CT)
Poster
Discussion
|
Randomized,
Double-blind, Placebo-
controlled Phase Three study of Ibrutinib Plus
Rituximab in Patients with Previously
Untreated Marginal Zone Lymphoma (MZL).
|
Session: Hematologic
Malignancies—Lymphoma and Chronic Lymphocytic Leukemia
Friday, June
4
8:00 a.m.
(CT)
Poster
|
Fixed-Duration (FD)
First-line Treatment (tx)
with Ibrutinib (I) Plus Venetoclax (V) for
Chronic Lymphocytic Leukemia (CLL)/small
Lymphocytic Lymphoma (SLL): Primary
Analysis of the FD Cohort of the Phase 2
CAPTIVATE study
|
Session: Hematologic
Malignancies—Lymphoma and Chronic Lymphocytic Leukemia
Monday, June
7
10:30 a.m. to 1:30
p.m. (CT)
Oral
Presentation
|
Venetoclax
|
Measurable Residual
Disease Response in
Acute Myeloid Leukemia Treated with
Venetoclax and Azacitidine
|
Session: Hematologic
Malignancies—Leukemia, Myelodysplastic Syndromes, and
Allotransplant
Friday, June
4
8:00 (CT)
Poster
|
Venetoclax and
Azacitidine Combination in
Chemotherapy Ineligible Untreated Patients
with Therapy-related Myeloid Neoplasms,
Antecedent Myelodysplastic Syndromes or
Myelodysplastic/Myeloproliferative
Neoplasms
|
Session: Hematologic
Malignancies—Leukemia, Myelodysplastic Syndromes, and
Allotransplant
Friday, June
4
8:00 (CT)
Poster
|
Phase 3 VERONA Study
of Venetoclax with
Azacitidine to Assess Change in Complete
Remission and Overall Survival in Treatment-
Naïve Higher-Risk Myelodysplastic
Syndromes
|
Session: Hematologic
Malignancies—Leukemia, Myelodysplastic Syndromes, and
Allotransplant
Friday, June
4
8:00 a.m.
(CT)
Poster
|
Comparison of Dose
Modification Strategies
to Address Expected Hematologic Toxicities
in Treatment-Naïve Higher-Risk (HR) MDS
Patients Treated with Venetoclax +
Azacitidine
|
Session: Hematologic
Malignancies—Leukemia, Myelodysplastic Syndromes, and
Allotransplant
Friday, June
4
8:00 a.m.
(CT)
Poster
|
Randomized, Phase III
Study of Early
Intervention with Venetoclax and
Obinutuzumab Versus Delayed Therapy with
Venetoclax and Obinutuzumab in Newly
Diagnosed Asymptomatic High-Risk Patients
with Chronic Lymphocytic Leukemia/Small
Lymphocytic Lymphoma (CLL/SLL): Evolve
CLL/SLL Study (SWOG S1925; NCT#04269902)
|
Session: Hematologic
Malignancies – Lymphoma and Chronic Lymphocytic Leukemia
Friday, June
4
8:00 a.m.
(CT)
Poster
|
Polatuzumab Vedotin +
Obinutuzumab +
Venetoclax in Patients with
Relapsed/refractory (R/R) Follicular
Lymphoma (FL): Primary Analysis of a Phase
1b/2 Trial
|
Session: Hematologic
Malignancies – Lymphoma and Chronic Lymphocytic Leukemia
Friday, June
4
8:00 a.m.
(CT)
Poster
|
Epcoritamab*
|
Subcutaneous
Epcoritamab in Patients With
Relapsed/Refractory B-Cell Non-Hodgkin
Lymphoma: Safety Profile and Antitumor
Activity
|
Session: Hematologic
Malignancies – Lymphoma and Chronic Lymphocytic Leukemia
Friday, June
4
8:00 a.m.
(CT)
Poster
|
Phase 3 Trial
(GCT3013-05) of Epcoritamab
Versus Standard of Care in Patients With
Relapsed or Refractory Diffuse Large B-Cell
Lymphoma (DLBCL)
|
Session: Hematologic
Malignancies—Lymphoma and Chronic Lymphocytic Leukemia
Friday, June
4
8:00 a.m.
(CT)
Poster
|
ABBV-155
|
A First-in-Human
Study of Mirzotamab
Clezutoclax as Monotherapy and in
Combination with Taxane Therapy in
Relapsed/Refractory Solid Tumors: Dose
Escalation Results
|
Session:
Developmental Therapeutics—Molecularly Targeted Agents and Tumor
Biology
Friday, June
4
8:00 a.m.
(CT)
Poster
|
ABBV-184
|
Phase 1
First-in-human Study of ABBV-184
Monotherapy in Adult Patients with Previously
Treated Acute Myeloid Leukemia or Non
-small Cell Lung Cancer
|
Session:
Developmental Therapeutics—Immunotherapy
Friday, June
4
8:00 a.m.
(CT)
Poster
|
The ASCO 2021 Annual Meeting abstracts are available at:
https://meetings.asco.org/am/abstracts
* Epcoritamab is being co-developed by Genmab and AbbVie as part
of the companies' broad oncology collaboration.
EHA 2021
Abstracts
|
Abstract
|
Presentation
Details
All Times in
CEST
|
Ibrutinib
|
Ibrutinib vs Placebo in
Combination with
Corticosteriods in Patients with New-Onset
Chronic Graft-Versus-Host Disease (cGVHD):
Results from the Randomized, Double-Blind
Phase 3 iNTEGRATE Study
|
Session: Stem Cell
Transplantation - cGVHD
Friday, June
11
9:00 a.m.
(CEST)
Oral
Presentation
|
Primary Analysis of
the Fixed-Duration Cohort
from the Phase 2 CAPTIVATE Study of First-
Line Ibrutinib + Venetoclax for Chronic
Lymphocytic Leukemia/Small Lymphocytic
Lymphoma
|
Session: Clinical
Trials with Targeted Therapies in CLL
Friday, June
11
9:00 a.m.
(CEST)
Oral
Presentation
|
Real-World Application of
National
Comprehensive Cancer Network Clinical
Practice Guidelines in Oncology (NCCN
Guidelines®) for CLL/SLL from the informCLL
Registry
|
Session: Chronic
Lymphocytic Leukemia and Related-Disorders – Clinical
Friday, June
11
Session: 9:00 a.m.
(CEST)
Poster
|
Effectiveness and
Safety of Ibrutinib in Chronic
Lymphocytic Leukemia (CLL) and Mantle Cell
Lymphoma (MCL) in Belgian Routine Clinical
Practice with a 3-Year Follow-up
|
Session: Chronic
Lymphocytic Leukemia and Related-Disorders – Clinical
Friday, June
11
Session: 9:00 a.m.
(CEST)
Poster
|
Ibrutinib,
Bendamustine, Rituximab for
Relapsed and Refractory Aggressive B Cell
Lymphoma – Final Analysis of Phase II Clinical
Trial
|
Session: Aggressive
Non-Hodgkin Lymphoma – Clinical
Friday, June
11
Session: 9:00 a.m.
(CEST)
Poster
|
Ibrutinib Treatment
in the First-Line Setting for
Patients with Chronic Lymphocytic Leukemia:
Up to 7 Years of Follow-up in the Resonate-2
Study
|
Session: Chronic
Lymphocytic Leukemia and Related-Disorders – Clinical
Friday, June
11
9:00 a.m.
(CEST)
Poster
|
Ibrutinib Plus Rituximab (IR)
vs Placebo Plus
Rituximab (R) for Waldenström's
Macroglobulinemia (WM): Final Analysis After
Five Years of Follow-up from the Randomized
Phar 3 INNOVATE Study
|
Session: Indolent and
Mantle-Cell Non-Hodgkins Lymphoma – Clinical
Friday, June
11
9:00 a.m.
(CEST)
Poster
|
Preliminary Clinical
Data from a Phase 1B
Study of Mavorixafor and Ibrutinib in Patients
with Waldenström's Macroglobulinemia with
MYD88 and CXCR4 Mutations
|
Session: Indolent and
Mantle-cell Non-Hodgkin Lymphoma - Clinical
Friday, June
11
9:00 a.m.
(CEST)
Poster
|
Role of Maintenance
Rituximab (MR) After
First-Line (1L) Bendamustine + Rituximab (BR)
or R-Chop in Patients (PTS) With Mantle Cell
Lymphoma (MCL) From a Large US Real-
World (RW) Cohort
|
Session: Indolent and
Mantle-Cell Non-Hodgkins Lymphoma – Clinical
Friday, June 11
9:00
(CEST)
Poster
|
Real-World Treatment
Patterns and Outcomes
of 3455 Previously Untreated Mantle Cell
Lymphoma Patients in U.S. Routine Clinical
Practice
|
Session: Indolent and
Mantle-Cell Non-Hodgkin Lymphoma
Friday, June
11
9:00
(CEST)
Poster
|
Venetoclax
|
Efficacy and Safety
of Venetoclax in
Combination with Gilteritinib for
Relapsed/Refractory FLT3-Mutated Acute
Myeloid Leukemia: Updated Analyses of a
Phase 1b Study
|
Session: Developments
in AML therapy
Friday, June
11
9:00 a.m.
(CEST)
Oral
Presentation
|
Measurable Residual
Disease Response in
Acute Myeloid Leukemia Treated with
Venetoclax and Azacitidine
|
Session: Developments
in AML therapy
Friday, June
11
9:00 a.m.
(CEST)
Oral
Presentation
|
Venetoclax-Obinutuzumab for Previously
Untreated Chronic Lymphocytic Leukemia: 4-
Year Follow-up Analysis of the Randomized
CLL14 Study
|
Session: Clinical
Trials with Targeted Therapies in CLL
Friday, June
11
9:00 a.m.
(CEST)
Oral
Presentation
|
Genetic Markers and
Outcome in Front Line Obinutuzumab Plus Chlorambucil or Venetoclax
- Updated Analysis of the CLL14
Trial
|
Session: New
Biological and Translational Insights in CLL
Friday, June
11
9:00 a.m.
(CEST)
Oral
Presentation
|
Primary Analysis of
the Fixed-Duration Cohort
From the Phase 2 CAPTIVATE Study of First-
Line Ibrutinib + Venetoclax for Chronic
Lymphocytic Leukemia/Small Lymphocytic
Leukemia
|
Session: Chronic
Lymphoid Malignancies
Friday, June
11
9:00 a.m.
(CEST)
Oral
Presentation
|
French Venetoclax
Observational Study
(VERONE): Real-world Study of Venetoclax
Monotherapy for Chronic Lymphocytic
Leukemia (CLL) in France
|
Session: Chronic
lymphocytic leukemia and related disorders – Clinical
Friday, June
11
9:00 a.m.
(CEST)
Poster
|
Safety and
Effectiveness of Venetoclax in
Combination with Rituximab in Elderly Patients
with Relapsed/Refractory CLL Treated Under
Real-Life Conditions – Data from the
Observational Study Verve
|
Session: Chronic
Lymphocytic Leukemia and Related-Disorders -- Clinical
Friday, June
11
9:00 a.m.
(CEST)
Poster
|
Updated Safety and
Efficacy of Venetoclax in
Combination with Azacitidine for the Treatment
of Patients with Treatment-Naïve Higher-Risk Myelodysplastic
Syndromes: Phase 1B Results
|
Session:
Myelodysplastic Syndromes - Clinical
Friday, June
11
9:00 a.m.
(CEST)
Poster
|
Comparison of Dose
Modification Strategies to
Address Expected Hematologic Toxicities in
Treatment-Naïve Higher-Risk (HR)
MDS Patients Treated with Venetoclax + Azacitidine
|
Session:
Myelodysplastic Syndromes - Clinical
Friday, June
11
9:00 a.m.
(CEST)
Poster
|
Venetoclax and
Azacitidine Combination in
Chemotherapy Ineligible Untreated Patients
with Therapy-related Myeloid Neoplasms,
Antecedent Myelodysplastic Syndromes or
Myelodysplastic/Myeloproliferative Neoplasms
|
Session:
Myelodysplastic syndromes - Clinical
Friday, June
11
9:00 a.m.
(CEST)
Poster
|
Relationship Between
Venetoclax Exposure
and Post-Remission Cytopenias in Subject with Treatment-Naïve Acute
Myeloid Leukemia
Treated with Venetoclax Plus Azacitidine in the
Viale-A Study
|
Session: Acute
Myeloid Leukemia - Clinical
Friday, June
11
9:00 a.m.
(CEST)
Poster
|
Venetoclax-Obinutuzumab Modulates Clonal
Growth: Results of a Population-based Minimal
Residual Disease Model from the Randomized
CLL14 Study
|
Session: Chronic
Lymphocytic Leukemia and Related Disorders - Clinical
Friday, June
11
9:00 a.m.
(CEST)
Poster
|
Impact of Unfavorable Genetics
on Minimal
Residual Disease (MRD) Response to Venetoclax+Rituximab Retreatment
in
Relapsed or Refractory Chronic Lymphocytic
Leukemia (R/R CLL): Phase 3 Murano
Substudy
|
Session: Chronic
lymphocytic leukemia and Related Disorders - Biology &
Translational Research
Friday, June
11
9:00 a.m.
(CEST)
Poster
|
Assessing Time to
Deterioration in HRQoL in
Patients with Multiple Myeloma Using
Venetoclax in Combination with Bortezomib
and Dexamethasone Compared with Patients
Using Bortezomib and Dexamethasone
|
Session: Myeloma and
Other Monoclonal Gammopathies – Clinical
Friday, June
11
9:00 a.m.
(CEST)
Poster
|
Cytopenia Management
in the Phase 3 VIALE-
C Study of Venetoclax Plus Low Dose
Cytarabine for Patients With Newly Diagnosed
Acute Myeloid Leukemia Ineligible for Intensive
Chemotherapy
|
Session: Acute
Myeloid Leukemia - Clinical
Friday, June
11
9:00 a.m.
(CEST)
Poster
|
Real World Treatment
Patterns and Clinical
Outcomes in Unfit Patients with AML Receiving
First Line Systemic Treatment or Best
Supportive Care (CURRENT). A Belgian
Subanalysis
|
Acute Myeloid
Leukemia - Clinical
Abstract publication
only
|
A Retrospective
Analysis of Clinical Outcomes of Patients with Chronic Lymphocytic
Leukemia
(CLL) Treated with Venetoclax in the Real-life
Setting in Spain (VENARES)
|
Chronic Lymphocytic
Leukemia and Related-Disorders - Clinical
Abstract publication
only
|
Navitoclax
|
Navitoclax and
Ruxolitinib for Patients with
Myelofibrosis and JAK Inhibitor Experience: Response Duration in
Phase 2 Study
|
Session:
Myeloproliferative Neoplasms - Clinical
Friday, June
11
9:00 a.m.
(CEST)
Poster
|
The EHA 2021 Congress abstracts are available at:
https://ehaweb.org/congress/eha-congress-2021/abstracts-and-awards/abstract-submission/abstracts-online/
About Ibrutinib (IMBRUVICA®)
IMBRUVICA (ibrutinib) 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. (Janssen). 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.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
Since its launch in 2013, IMBRUVICA® has
received 11 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 macroglobulinemia; 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 101 countries
and has been used to treat more than 200,000 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.
Since 2019, the National Comprehensive Cancer
Network® (NCCN®), a not-for-profit
alliance of 28 leading cancer centers devoted to patient care,
research, and education, recommends ibrutinib
(IMBRUVICA®) as a preferred regimen for the
initial treatment of CLL/SLL and has Category 1 treatment status
for treatment-naïve patients without deletion 17p. In January
2020, the NCCN Guidelines® were updated to elevate
IMBRUVICA® with or without rituximab from other
recommended regimens to a preferred regimen for the treatment of
relapsed/refractory MCL, regardless of duration of response to
prior chemoimmunotherapy. As of September 2020, the NCCN
guidelines were updated to reflect IMBRUVICA®
with or without rituximab as the only Category 1 preferred regimen
for both untreated and previously treated WM patients.
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 Side Effect Information5
Before taking IMBRUVICA®, tell your healthcare
provider about all of your medical conditions, including if
you:
- have had recent surgery or plan to have surgery. Your
healthcare provider may stop IMBRUVICA® for any planned
medical, surgical, or dental procedure.
- have bleeding problems.
- have or had heart rhythm problems, smoke, or have a medical
condition that increases your risk of heart disease, such as high
blood pressure, high cholesterol, or diabetes.
- have an infection.
- have liver problems.
- are pregnant or plan to become pregnant. IMBRUVICA®
can harm your unborn baby. If you are able to become pregnant, your
healthcare provider will do a pregnancy test before starting
treatment with IMBRUVICA®. Tell your healthcare provider
if you are pregnant or think you may be pregnant during treatment
with IMBRUVICA®.
-
- Females who are able to become pregnant should use
effective birth control (contraception) during treatment with
IMBRUVICA® and for 1 month after the last
dose.
- Males with female partners who are able to become
pregnant should use effective birth control, such as condoms,
during treatment with IMBRUVICA® and for 1 month
after the last dose.
- are breastfeeding or plan to breastfeed. Do not breastfeed
during treatment with IMBRUVICA® and for 1 week
after the last dose.
Tell your healthcare provider about all the medicines you
take, including prescription and over-the-counter
medicines, vitamins, and herbal supplements. Taking
IMBRUVICA® with certain other medicines may affect
how IMBRUVICA® works and can cause side
effects.
How should I take IMBRUVICA®?
- Take IMBRUVICA® exactly as your healthcare provider
tells you to take it.
- Take IMBRUVICA® 1 time a day.
- Swallow IMBRUVICA® capsules or tablets whole with a
glass of water.
- Do not open, break or chew IMBRUVICA® capsules.
- Do not cut, crush or chew IMBRUVICA® tablets.
- Take IMBRUVICA® at about the same time each
day.
- If you miss a dose of IMBRUVICA® take it as soon as
you remember on the same day. Take your next dose of
IMBRUVICA® at your regular time on the next day. Do not
take extra doses of IMBRUVICA® to make up for a missed
dose.
-
- If you take too much IMBRUVICA® call your
healthcare provider or go to the nearest hospital emergency room
right away.
What should I avoid while taking
IMBRUVICA®?
- You should not drink grapefruit juice, eat grapefruit, or eat
Seville oranges (often used in
marmalades) during treatment with IMBRUVICA®. These
products may increase the amount of IMBRUVICA® in your
blood.
What are the possible side effects of
IMBRUVICA®?
IMBRUVICA® may
cause serious side effects, including:
- Bleeding problems (hemorrhage) are common during
treatment with IMBRUVICA®, and can also be serious and
may lead to death. Your risk of bleeding may increase if you are
also taking a blood thinner medicine. Tell your healthcare provider
if you have any signs of bleeding, including: blood in your stools
or black stools (looks like tar), pink or brown urine, unexpected
bleeding, or bleeding that is severe or that you cannot control,
vomit blood or vomit looks like coffee grounds, cough up blood or
blood clots, increased bruising, dizziness, weakness, confusion,
change in your speech, or a headache that lasts a long time or
severe headache.
- Infections can happen during treatment with
IMBRUVICA®. These infections can be serious and may lead
to death. Tell your healthcare provider right away if you have
fever, chills, weakness, confusion, or other signs or symptoms of
an infection during treatment with IMBRUVICA®.
- Decrease in blood cell counts. Decreased blood counts
(white blood cells, platelets, and red blood cells) are common with
IMBRUVICA®, but can also be severe. Your healthcare
provider should do monthly blood tests to check your blood
counts.
- Heart problems. Serious heart rhythm problems
(ventricular arrhythmias, atrial fibrillation, and atrial flutter),
heart failure, and death have happened in people treated with
IMBRUVICA®, especially in people who have an increased
risk for heart disease, have an infection, or who have had heart
rhythm problems in the past. Tell your healthcare provider if you
get any symptoms of heart problems, such as feeling as if your
heart is beating fast and irregular, lightheadedness, dizziness,
shortness of breath, swelling of the feet, ankles, or legs, chest
discomfort, or you faint. If you develop any of these symptoms,
your healthcare provider may do a test to check your heart (ECG)
and may change your IMBRUVICA® dose.
- High blood pressure (hypertension). New or worsening
high blood pressure has happened in people treated with
IMBRUVICA®. Your healthcare provider may start you on
blood pressure medicine or change current medicines to treat your
blood pressure.
- Second primary cancers. New cancers have happened during
treatment with IMBRUVICA®, including cancers of the skin
or other organs.
- Tumor lysis syndrome (TLS). TLS is caused by the fast
breakdown of cancer cells. TLS can cause kidney failure and the
need for dialysis treatment, abnormal heart rhythm, seizure, and
sometimes death. Your healthcare provider may do blood tests to
check you for TLS.
The most common side effects of IMBRUVICA® in
adults with B-cell malignancies (MCL, CLL/SLL, WM and MZL)
include:
- diarrhea
- tiredness
- muscle and bone pain
- rash
- bruising
The most common side effects of IMBRUVICA® in
adults with cGVHD include:
- tiredness
- bruising
- diarrhea
- mouth sores (stomatitis)
- muscle spasms
- nausea
- pneumonia
Diarrhea is a common side effect in people who take
IMBRUVICA®. Drink plenty of fluids during treatment with
IMBRUVICA® to help reduce your risk of losing too
much fluid (dehydration) due to diarrhea. Tell your healthcare
provider if you have diarrhea that does not go away.
These
are not all the possible side effects of IMBRUVICA®.
Call your doctor for medical advice about side effects. You may
report side effects to FDA at 1-800-FDA-1088.
General information about the safe and effective use of
IMBRUVICA®
Medicines are sometimes
prescribed for purposes other than those listed in a Patient
Information leaflet. Do not use IMBRUVICA® for a
condition for which it was not prescribed. Do not give
IMBRUVICA® to other people, even if they have the
same symptoms that you have. It may harm them. You can ask your
pharmacist or healthcare provider for information about
IMBRUVICA® that is written for health
professionals.
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. VENCLXEXTA/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
cancers. Venetoclax is approved in more than 80 countries,
including the U.S.
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. When
restarting VENCLEXTA after stopping for 1 week or longer, your
healthcare provider may again check for your risk of TLS and change
your dose.
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 and for 1 week after the last dose.
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 and may pause
dosing.
- 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 nausea; diarrhea; low platelet count;
constipation; low white blood cell count; fever with low white
blood cell count; tiredness; vomiting; swelling of arms, legs,
hands, or feet; fever; infection in lungs; shortness of breath;
bleeding; low red blood cell count; rash; stomach (abdominal) pain;
infection in your blood; muscle and joint pain; dizziness; cough;
sore throat; and low blood pressure.
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. Call your doctor for medical advice about side
effects.
You are encouraged to report side effects of prescription
drug to the FDA. Visit www.fda.gov/medwatch or call
1-800-FDA-1088.
If you cannot afford your medication, contact
genentech-access.com/patient/brands/venclexta for
assistance.
The full U.S. prescribing information, including Medication
Guide, for VENCLEXTA® can be
found here.
Indication and Important VENCLYXTO® (venetoclax)
EU Safety Information7
Indication
Venclyxto® in combination with obinutuzumab is
indicated for the treatment of adult patients with previously
untreated chronic lymphocytic leukaemia (CLL).
Venclyxto® in combination with rituximab is
indicated for the treatment of adult patients with 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
TLS,
including fatal events, has occurred in patients with previously
treated CLL with high tumour 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 sepsis with fatal outcome have been
reported. Monitoring of any signs and symptoms of infection is
required. Suspected infections should receive prompt
treatment including antimicrobials and dose interruption or
reduction as appropriate.
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: moderate or strong
CYP3A inhibitors must be used, physicians should refer to the
VENCLYXTO® summary of product characteristics
(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 studies with obinutuzumab or rituximab were
neutropenia, diarrhoea, and upper respiratory tract
infection. In the monotherapy studies, the most common
adverse reactions were neutropenia/neutrophil count decreased,
diarrhoea, nausea, anaemia, fatigue, and upper respiratory tract
infection.
The most frequently occurring serious adverse reactions
(>=2%) in patients receiving venetoclax in combination with
obinutuzumab or rituximab were pneumonia, sepsis, febrile
neutropenia, and TLS. In the monotherapy studies, the most
frequently reported serious adverse reactions (>=2%) were
pneumonia and febrile neutropenia.
Discontinuations due to adverse reactions occurred in 16% of
patients treated with venetoclax in combination with obinutuzumab
or rituximab in the CLL14 and Murano studies respectively. In
the monotherapy studies with venetoclax, 11% of patients
discontinued due to adverse reactions.
Dosage reductions due to adverse reactions occurred in 21% of
patients treated with the combination of venetoclax and
obinutuzumab in CLL14 and in 15% of patients treated with the
combination of venetoclax and in Murano and in 14% of patients
treated with venetoclax in the monotherapy
studies. The most common adverse reaction that
led to dose interruptions was neutropenia.
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 https://www.ema.europa.eu/en/documents/product-information/venclyxto-epar-product-information_en.pdf.
Globally, prescribing information varies; refer to the individual
country product label for complete information.
About AbbVie in Oncology
At AbbVie, we are committed to transforming standards of care
for multiple blood cancers while advancing a dynamic pipeline of
investigational therapies across a range of cancer types. Our
dedicated and experienced team joins forces with innovative
partners to accelerate the delivery of potentially breakthrough
medicines. We are evaluating more than 20 investigational medicines
in over 300 clinical trials across some of the world's most
widespread and debilitating cancers. As we work to have a
remarkable impact on people's lives, we are committed to exploring
solutions to help patients obtain access to our cancer medicines.
For more information, please visit
http://www.abbvie.com/oncology.
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines
that solve serious health issues today and address the medical
challenges of tomorrow. We strive to have a remarkable impact on
people's lives across several key therapeutic areas: immunology,
oncology, neuroscience, eye care, virology, women's health and
gastroenterology, in addition to products and services across its
Allergan Aesthetics portfolio. For more information about AbbVie,
please visit us at www.abbvie.com. Follow
@abbvie on Twitter, Facebook, Instagram, YouTube and
LinkedIn.
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, failure to realize
the expected benefits from AbbVie's acquisition of Allergan plc
("Allergan"), failure to promptly and effectively integrate
Allergan's businesses, competition from other products, challenges
to intellectual property, difficulties inherent in the research and
development process, adverse litigation or government action,
changes to laws and regulations applicable to our industry and the
impact of public health outbreaks, epidemics or pandemics, such as
COVID-19. 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 2020 Annual Report on Form 10-K, which has been filed with
the Securities and Exchange Commission, as updated by its
subsequent Quarterly Reports on Form 10-Q. 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.
REFERENCES
1 Genetics Home Reference.
Isolated growth hormone deficiency.
http://ghr.nlm.nih.gov/condition/isolated-growth-hormone-deficiency.
Accessed November 2020.
2 Turetsky, et al. Single cell imaging of Bruton's
Tyrosine Kinase using an irreversible inhibitor. Scientific
Reports. volume 4, Article number: 4782 (2014)
3 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.
4 IMBRUVICA U.S. Prescribing Information, April
2020.
5 IMBRUVICA U.S. Prescribing Information, April
2020.
6 VENCLEXTA (venetoclax) [Package Insert]. North
Chicago, IL.: AbbVie Inc.
7 Summary of Product Characteristics for VENCLYXTO
(venetoclax). Ludwigshafen, Germany: AbbVie Deutschland GmbH & Co.
KG.
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