NORTH CHICAGO, Ill.,
Nov. 5, 2020 /PRNewswire/
-- AbbVie (NYSE: ABBV) announced that it will present blood
cancer data from nearly 40 abstracts, including 10 oral
presentations, across 11 cancer types during the upcoming virtual
American Society of Hematology (ASH) Annual Meeting and Exposition,
December 5-8.
"We are steadfast in our commitment to advancing discovery,
innovation and care for people with blood cancers," said
Mohamed Zaki, M.D., Ph.D, vice
president and global head of oncology development, AbbVie. "We are
looking forward to sharing findings from our expanding hematology
oncology portfolio and continued research and treatment advances
during the ASH annual meeting."
AbbVie will present updated results from the CAPTIVATE study,
evaluating disease-free survival in previously untreated patients
with chronic lymphocyctic leukemia (CLL)/small lymphocytic leukemia
(SLL) who received an ibrutinib (IMBRUVICA®) +
venetoclax (VENCLEXTA®/ VENCLYXTO®)
combination regimen. As well, an update on a 5-year analysis of the
MURANO study in a subset of relapsed/refractory CLL patients
following venetoclax-(VENCLEXTA®/ VENCLYXTO®)
rituximab therapy and 8-year follow-up ibrutinib
(IMBRUVICA®) data in high-risk patients with CLL
(RESONATE-2 and iLLUMINATE) will be presented. AbbVie's new
partners, Genmab and I-Mab will offer data from recently announced
collaborations.
Details about presentations are as follows:
Abstract
|
Presentation
Details
All times
CT
|
Ibrutinib
|
Ibrutinib (Ibr) Plus
Venetoclax (Ven) for First-Line Treatment of Chronic Lymphocytic
Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL): 1-Year
Disease-Free Survival (DFS) Results From the MRD Cohort of the
Phase 2 CAPTIVATE Study
|
Session 642. CLL:
Therapy, excluding Transplantation
Saturday, December 5
Session: 9:30 a.m. - 11:00 a.m.
Oral Presentation: 11:30 a.m.
|
Five-Year Follow-Up of
Ibrutinib Plus Rituximab vs Placebo Plus Rituximab for
Waldenstrom's Macroglobulinemia: Final Analysis From the Randomized
Phase 3 iNNOVATE™ Study
|
Session 623. Mantle
Cell, Follicular, and Other Indolent B-Cell Lymphoma—Clinical
Studies: Clinical studies in Waldenstrom's Macroglobulinemia,
Marginal Zone Lymphoma and Hairy Cell Leukemia
Sunday, December 6
Session: 9:30 a.m. - 11:00 a.m.
Oral Presentation: 11:30 a.m.
|
Rarity of B-Cell
Receptor Pathway Mutations in Progression-Free Patients With
Chronic Lymphocytic Leukemia (CLL) During First-Line Versus
Relapsed/Refractory (R/R) Treatment With Ibrutinib (Ibr)
|
Session 642. CLL:
Therapy, excluding Transplantation: Poster II
Sunday, December
6
|
Outcomes of
First-Line Ibrutinib in Patients With Chronic Lymphocytic
Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) and High-Risk Genomic
Features With Up To 6.5 Years Follow-Up: Integrated Analysis of Two
Phase 3 Studies (RESONATE-2 and iLLUMINATE)
|
Session 642. CLL:
Therapy, excluding Transplantation: Poster II
Sunday, December 6
|
Long-Term Efficacy of
First-line Ibrutinib Treatment for Chronic Lymphocytic Leukemia
(CLL) With 4 Years of Follow-Up in Patients With TP53 Aberrations
(del(17p) or TP53 Mutation): A Pooled Analysis From 4 Clinical
Trials
|
Session 642. CLL:
Therapy, excluding Transplantation: Poster II
Sunday, December
6
|
Real-World Prognostic
Biomarker Testing, Treatment Patterns and Dosing Among 1461
Patients (pts) with Chronic Lymphocytic Leukemia/Small Lymphocytic
Lymphoma (CLL/SLL) from the informCLL™ Prospective Observational
Registry
|
Session 642. CLL:
Therapy, excluding Transplantation: Poster II
Monday, December 7,
Session: 7:00 a.m. – 8:30 a.m.
Oral Presentation: 10:15 a.m.
|
Ibrutinib Plus
Venetoclax in Patients with Relapsed/Refractory Mantle Cell
Lymphoma: Results From the Safety Run-In Period of the Phase 3
SYMPATICO Study
|
Session 623. Mantle
Cell, Follicular, and Other Indolent B-Cell Lymphoma—Clinical
Studies: Poster III
Monday, December
7
|
Long-Term Follow-Up of
Ibrutinib Treatment for Rituximab-Refractory Waldenström's
Macroglobulinemia: Final Analysis of the Open-Label Substudy of the
Phase 3 iNNOVATE™ Trial
|
Session 623. Mantle
Cell, Follicular, and Other Indolent B-Cell Lymphoma—Clinical
Studies: Poster III
Monday, December 7
|
Venetoclax in
Acute Myeloid Leukemia (AML)
|
Venetoclax Crosses
the Blood Brain Barrier: A Pharmacokinetic Analysis of the
Cerebrospinal Fluid in Pediatric Leukemia Patients
|
Session 613. Acute
Myeloid Leukemia: Clinical Studies: Poster I
Saturday, December
5
|
Venetoclax Alone or
in Combination with Chemotherapy: Responses in Pediatric Patients
with Relapsed/Refractory Acute Myeloid Leukemia with Heterogenous
Genomic Profiles
|
Session 615. Acute
Myeloid Leukemia: Commercially Available Therapy, excluding
Transplantation: Poster I
Saturday, December
5
|
Proposed Scheme for
Dosing Venetoclax in Pediatric Patients with Relapsed/Refractory
Acute Myeloid Leukemia: Analysis of Developmental Pharmacokinetics
and Exposure-Response Relationships
|
Session 613. Acute
Myeloid Leukemia: Clinical Studies: Poster I
Saturday, December
5
|
Results of Venetoclax
and Azacitidine Combination in Chemotherapy Ineligible Untreated
Patients with Acute Myeloid Leukemia with IDH 1/2
Mutations
|
Session 613. Acute
Myeloid Leukemia: Potpourri of Potential Practice Changing
Studies
Sunday, December
6
Session: 9:00 a.m. -
5:30 p.m.
Oral Presentation:
4:45 p.m.
|
Efficacy and Safety
of Venetoclax in Combination with Gilteritinib for
Relapsed/Refractory FLT3-Mutated Acute Myeloid Leukemia in the
Expansion Cohort of a Phase 1b Study
|
Session 613. Acute
Myeloid Leukemia: Novel Therapies and Treatment
Approaches
Sunday, December
6
Session: 9:00 a.m. -
5:30 p.m.
Oral Presentation:
12:15 p.m.
|
Cytopenia Management
in Patients with Newly Diagnosed Acute Myeloid Leukemia Treated
with Venetoclax Plus Azacitidine in the VIALE-A Study
|
Session 615. Acute
Myeloid Leukemia: Commercially Available Therapy, excluding
Transplantation: Poster II
Sunday, December
6
|
Characteristics and
Outcomes of Newly Diagnosed Acute Myeloid Leukemia Patients
Receiving Venetoclax Combinations vs Other Therapies: Results from
the AML Real World EvidenCe (ARC) Initiative
|
Session 906. Outcomes
Research—Malignant Conditions (Myeloid Disease): Poster
II
Sunday, December
6
|
Results of Venetoclax
and Azacitidine Combination in Chemotherapy Ineligible Untreated
Patients with Acute Myeloid Leukemia with FLT3 Mutations
|
Session 613. Acute
Myeloid Leukemia: Clinical Studies: Poster II
Sunday, December 6
|
Real-World Treatment
Patterns and Clinical Outcomes in Unfit Patients with AML Receiving
First-Line Systemic Treatment or Best Supportive Care (CURRENT):
Final Analysis
|
Session 613. Acute
Myeloid Leukemia: Clinical Studies: Poster II
Sunday, December
6
|
First Results from a
Nationwide Prospective Non-Interventional Study of Venetoclax-Based
1st Line Therapies in Patients with Acute Myeloid Leukemia (AML) –
REVIVE Study
|
Session 613. Acute
Myeloid Leukemia: Clinical Studies: Poster III
Monday, December
7
|
CYP3A Inhibitors and Impact of
These Agents on Outcomes in Patients with Acute Myeloid Leukemia
Treated with Venetoclax Plus Azacitidine on the VIALE-A
Study
|
Session 615. Acute
Myeloid Leukemia: Commercially Available Therapy, excluding
Transplantation: Poster III
Monday, December
7
|
Venetoclax in
Acute Lymphoblastic Leukemia (ALL)
|
Venetoclax and
Navitoclax in Pediatric Patients With Acute Lymphoblastic Leukemia
and Lymphoblastic Lymphoma
|
Session 614. Acute
Lymphoblastic Leukemia: Therapy, excluding Transplantation:
Targeted Therapies
Sunday, December
6
Session: 9:00 a.m. -
5:30 p.m.
Oral Presentation:
4:30 p.m.
|
Pediatric Patients
with Relapsed/Refractory Acute Lymphoblastic Leukemia Harboring
Heterogenous Genomic Profiles Respond to Venetoclax in Combination
with Chemotherapy
|
Session 612. Acute
Lymphoblastic Leukemia: Clinical Studies: Poster III
Monday, December
7
|
Venetoclax in
Chronic Lymphocytic Leukemia (CLL)
|
Five-Year Analysis of
MURANO Study Demonstrates Enduring uMRD in a Subset of
Relapsed/Refractory (R/R) CLL Patients Following Fixed Duration
Venetoclax-Rituximab Therapy
|
Session 642. CLL:
Therapy, excluding Transplantation
Saturday, December
5
Session: 9:00 a.m.-
5:30 p.m.
Oral Presentation: 12:00 p.m.
|
Clonal Dynamics After
Venetoclax-Obinutuzumab Therapy: Novel Insights From the
Randomized, Phase 3 CLL14 Trial
|
Session 642. CLL:
Therapy, excluding Transplantation
Saturday, December
5
Session: 9:00 a.m. -
5:30 p.m.
Oral Presentation:
12:30 p.m.
|
Characteristics and
Outcome of Patients with Chronic Lymphocytic Leukaemia and Partial
Response to Venetoclax-Oinutuzumab
|
Session 642. CLL:
Therapy, excluding Transplantation: Poster I
Saturday, December
5
|
Assessment of Tumor Lysis
Syndrome in Patients with Chronic Lymphocytic Leukemia Treated With
Venetoclax in the Clinical and Post-Marketing
Settings
|
Session 642. CLL:
Therapy, excluding Transplantation: Poster II
Sunday, December
6
|
Efficacy of
Subsequent Novel Targeted Therapies, Including Repeat
Venetoclax-Rituximab (VenR), in Patients with Relapsed/Refractory
CLL Previously Treated With VenR in the MURANO Study
|
Session 642. CLL:
Therapy, excluding Transplantation: Poster III
Monday, December
7
|
Debulking Regimens
Prior To Initiating Venetoclax Therapy in Untreated Patients with
Chronic Lymphocytic Leukemia: Safety and Efficacy Results from a
Phase 3b Study
|
Session 642. CLL:
Therapy, excluding Transplantation: Poster III
Monday, December
7
|
A Multicenter,
Retrospective Study of Accelerated Venetoclax Ramp-Up in Patients
with Relapsed/Refractory Chronic Lymphocytic Leukemia
|
Session 642. CLL:
Therapy, excluding Transplantation: Poster III
Monday, December
7
|
Venetoclax in
Multiple Myeloma (MM)
|
Assessment of Minimal
Residual Disease by Next-generation Sequencing and
Fluorodeoxyglucose-positron Emission Tomography in Patients with
Relapsed/Refractory Multiple Myeloma Treated with Venetoclax in
Combination with Carfilzomib and Dexamethasone
|
Session 651. Myeloma:
Biology and Pathophysiology, excluding Therapy: Poster II
Sunday, December 6
|
A Phase 3, Randomized,
Multicenter, Open-Label Study of Venetoclax or Pomalidomide in
Combination With Dexamethasone in Patients With T(11;14)-Positive
Relapsed/Refractory Multiple Myeloma
|
Session 653. Myeloma:
Therapy, excluding Transplantation: Poster II
Sunday, December
6
|
Integrative Analysis
of the Genomic and Transcriptomic Landscape of Relapsed/Refractory
Multiple Myeloma Patients Treated with Venetoclax in Combination
with Bortezomib and Dexamethasone: Biomarker Analyses from the
Phase 3 BELLINI Study
|
Session 653. Myeloma:
Therapy, excluding Transplantation: Poster III
Monday, December 7
|
Navitoclax
|
The Addition of
Navitoclax to Ruxolitinib Demonstrates Efficacy Within Different
High-Risk Populations in Patients with Relapsed/Refractory
Myelofibrosis
|
Session 634.
Myeloproliferative Syndromes: Clinical: New Therapies and
JAKi-based Combinations for Myelofibrosis
Saturday, December
5
Session: 9:00 a.m. -
5:30 p.m.
Oral Presentation:
9:45 a.m.
|
Epcoritamab*
|
Subcutaneous
Epcoritamab Induces Complete Responses With an Encouraging Safety
Profile Across Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma
Subtypes Including Patients With Prior CAR-T Therapy: Updated Dose
Escalation Data Epcoritamab Demonstrates a Consistent and Favorable
Safety Profile, With No Grade ≥3 CRS Events and Limited
Neurotoxicity, in Support of Outpatient
*Collaboration with Genmab
|
Session 626.
Aggressive Lymphoma (Diffuse Large B-Cell and Other Aggressive
B-Cell Non-Hodgkin Lymphomas)—Results from Prospective Clinical
Trials: Updates and advances in bispecific antibody therapies and
autologous CAR-T approaches
Sunday, December
6
Session: 9:00 a.m. -
5:30 p.m.
Oral Presentation:
2:30 p.m.
|
Novel
Semi-Mechanistic Model Leveraging Preclinical and Clinical Data to
Inform the Recommended Phase 2 Dose (RP2D) Selection for
Epcoritamab (DuoBody CD3xCD20)
*Collaboration with
Genmab
|
Session 605.
Molecular Pharmacology, Drug Resistance—Lymphoid and Other
Diseases: Poster III
Monday, December
7
|
Lemzoparlimab*
|
A Phase I/IIa Study
of Lemzoparlimab, a Monoclonal Antibody Targeting CD47, in Patients
with Relapsed and/or Refractory Acute Myeloid Leukemia (AML) and
Myelodysplastic Syndrome (MDS): Initial Phase I Results
*Collaboration with
I-Mab
|
Abstract publication
only
|
The ASH 2020 Annual Meeting abstracts are available at
hematology.org/meetings/annual-meeting/abstracts.
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; 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 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.
As of early 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 February 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. In
September 2020, the NCCN guidelines
were updated to elevate IMBRUVICA with or without rituximab as the
only Category 1 preferred regimen for treatment-naïve 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 Information
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 rhythm problems (ventricular arrhythmias, atrial
fibrillation and atrial flutter). Serious heart rhythm
problems 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 rhythm problems, such as feeling as if
your heart is beating fast and irregular, lightheadedness,
dizziness, shortness of breath, 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 Venetoclax (VENCLEXTA®/
VENCLYXTO®)
VENCLEXTA (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 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.
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.
Globally, prescribing information varies; refer to the
individual country product label for complete information.
Epcoritamab is being co-developed by Genmab and AbbVie.
In September 2020, I-Mab and
AbbVie entered into a global collaboration agreement to develop and
commercialize lemzoparlimab. Subject to pre-closing conditions,
both companies will be collaborating to further advance
the clinical development of lemzoparlimab for the treatment
of multiple cancers globally and in
China.
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 2019 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 VENCLEXTA (venetoclax) [Package Insert].
North Chicago, IL.: AbbVie
Inc.
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SOURCE AbbVie