NORTH CHICAGO, Ill.,
Nov. 4, 2021 /PRNewswire/
-- AbbVie (NYSE: ABBV) will present results from nearly 30
abstracts across eight types of cancer during the upcoming American
Society of Hematology (ASH) Annual Meeting (December 11-14) in Atlanta, Georgia.
"We are dedicated to transforming standards of care for people
living with blood cancers," said Mohamed
Zaki, M.D., Ph.D, vice president and global head of oncology
development, AbbVie. "The data we are presenting at the ASH Annual
Meeting build on our deep expertise in the development of novel
treatments that have the potential to make a remarkable difference
for people living with blood cancers and other tumor types with
significant unmet needs."
At ASH, AbbVie will present data from the Phase 2 CAPTIVATE and
Phase 3 GLOW studies evaluating minimal residual disease and
disease-free survival outcomes with fixed duration
treatment in patients with chronic lymphocytic leukemia
(CLL)/small lymphocytic leukemia (SLL) who received the
ibrutinib (IMBRUVICA®) + venetoclax
(VENCLEXTA®/ VENCLYXTO®) combination
regimen. In addition, AbbVie will present results from several
studies, including: multiple abstracts evaluating venetoclax in
approved indications – CLL, acute myeloid leukemia (AML) – and
investigational indications – multiple myeloma (MM) and
myelodysplastic syndromes (MDS); the updated results of ABBV-383
(an anti-BCMA x CD3 bispecific antibody); three abstracts on
epcoritamab (an anti-CD20 x CD3 bispecific antibody) in partnership
with Genmab; and an abstract on lemzoparlimab (an anti-CD47
antibody) in partnership with I-Mab.
Details about presentations are as follows:
ASH 2021
Abstracts
|
Abstract
|
Presentation
Details
All times in
CT
|
Ibrutinib
|
First-Line Treatment
with Ibrutinib (Ibr) Plus Venetoclax (Ven) for Chronic Lymphocytic
Leukemia (CLL): 2-Year Post-Randomization Disease-Free Survival
(DFS) Results From the Minimal Residual Disease (MRD) Cohort of the
Phase 2 CAPTIVATE Study
|
Session: Chronic
Lymphocytic Leukemia: Clinical and Epidemiological: Combination
Small Molecules
Saturday, December
11
8:45 a.m.
CT
Oral
Presentation
|
First Prospective
Data on Minimal Residual Disease (MRD) Outcomes After
Fixed-Duration Ibrutinib Plus Venetoclax (Ibr+Ven) Versus
Chlorambucil Plus Obinutuzumab (Clb+O) for First-Line Treatment of
CLL in Elderly or Unfit Patients: The GLOW Study
|
Session: Chronic
Lymphocytic Leukemia: Clinical and Epidemiological: Combination
Small Molecules
Saturday, December
11
9:15 a.m.
CT
Oral
Presentation
|
Impact of Dosing
Frequency of Oral Oncolytics on Refill Adherence Among Patients
with Hematological Malignancies
|
Session: Outcomes
Research—Lymphoid Malignancies: Poster I
Saturday, December
11
4:30 – 6:30 p.m.
CT
Poster
Presentation
|
Application of
National Comprehensive Cancer Network Clinical Practice Guidelines
in Oncology (NCCN Guidelines®) for CLL/SLL from the
inform CLL Real-World Registry
|
Session: Outcomes
Research—Lymphoid Malignancies: Poster I
Saturday, December
11
4:30 – 6:30 p.m.
CT
Poster
Presentation
|
Venetoclax
|
Final Overall
Survival Results from BELLINI, a Phase 3 Study of Venetoclax or
Placebo in Combination With Bortezomib and Dexamethasone in
Relapsed/Refractory Multiple Myeloma
|
Session: Myeloma and
Plasma Cell Dyscrasias: Clinical-Prospective Therapeutic Trials:
Phase 2 and 3 Trials in Myeloma
Saturday, December
11
9:45 a.m.
CT
Oral
Presentation
|
Outcomes in Patients
with Poor-risk Cytogenetics with or without TP53 Mutations Treated
with Venetoclax Combined with Hypomethylating Agents
|
Session: Acute
Myeloid Leukemia: Biology, Cytogenetics, and Molecular Markers in
Diagnosis and Prognosis: Response Prediction across the Spectrum of
DNA, RNA, Protein and Ex Vivo Cells
Saturday, December
11
1:00 – 1:30 p.m.
CT
Oral
Presentation
|
Molecular Responses
are Observed Across Mutational Spectrum in Treatment-Naïve
Higher-Risk Myelodysplastic Syndrome Patients Treated with
Venetoclax plus Azacitidine
|
Session:
Myelodysplastic Syndromes – Clinical and Epidemiological: Treatment
of High-Risk Myelodysplastic Syndrome
Saturday, December
11
1:00 – 1:30 p.m.
CT
Oral
Presentation
|
Venetoclax in
Combination with Gilteritinib Demonstrates Molecular Clearance of
FLT3 Mutation in Relapsed/Refractory FLT3-mutated Acute Myeloid
Leukemia
|
Session: Acute
Myeloid Leukemias: Commercially Available Therapies, Excluding
Transplantation and Cellular Immunotherapies: Current approach to
FLT3 mutated AML
Monday, December
13
1:45 – 3:15 p.m.
CT
Oral
Presentation
|
Venetoclax and
Azacitidine in the Treatment of Patients with Relapsed/Refractory
Myelodysplastic Syndrome
|
Session:
Myelodysplastic Syndromes – Clinical and Epidemiological: Treatment
of High Risk and Relapsed/Refractory Myelodysplastic
Syndrome
Sunday, December
12
3:30 – 5:00 p.m.
CT
Oral
Presentation
|
Safety and
Preliminary Efficacy From the Expansion Cohort of a Phase 1/2 Study
of Venetoclax Plus Daratumumab and Dexamethasone vs Daratumumab
Plus Bortezomib and Dexamethasone in Patients With t(11;14)
Relapsed/Refractory Multiple Myeloma
|
Session: Dyscrasias:
Clinical and Epidemiological: Challenges in Multiple Myeloma
Therapy: Adopting New Approaches for Relapse and Monitor
Monday, December
13
3:30 p.m.
CT
Oral
Presentation
|
Real-World Management
of Patients with Newly Diagnosed Acute Myeloid Leukemia Treated
with Venetoclax-based Regimens: Results from the AML Real world
evidenCe (ARC) Initiative
|
Session: Acute
Myeloid Leukemias: Commercially Available Therapies, Excluding
Transplantation and Cellular Immunotherapies: Poster I
Saturday, December
11
4:30 – 6:30 p.m.
CT
Poster
|
Rapid and Sustained
Reduction of Immunosuppressive T-cells and Focusing of the T-cell
Repertoire in t(11;14) Relapsed/Refractory Multiple Myeloma
Patients Treated with Venetoclax in Combination with Daratumumab
and Dexamethasone
|
Session: Multiple
Myeloma and Plasma cell Dyscrasias: Clinical and Epidemiological:
Poster I
Saturday, December
11
5:00 – 7:00 p.m.
CT
Poster
|
A Retrospective
Analysis of Patients with Chronic Lymphocytic Leukemia (CLL)
Treated with Venetoclax in the Real-life Setting in Spain
(Venares)
|
Session: Chronic
Lymphocytic Leukemia: Clinical and Epidemiological: Poster
I
Saturday, December
11
5:00 – 7:00 p.m.
CT
Poster
|
Treatment Initiation
of Venetoclax in Combination With Azacitidine or Decitabine in an
Outpatient Setting in Patients With Untreated Acute Myeloid
Leukemia
|
Session: Acute
Myeloid Leukemias: Commercially Available Therapies, Excluding
Transplantation and Cellular Immunotherapies
Saturday, December
11
4:30 – 6:30 p.m.
CT
Poster
|
ReVenG: A Phase 2
Study of Venetoclax Plus Obinutuzumab Retreatment in Patients with
Relapsed Chronic Lymphocytic Leukemia
|
Session: Chronic
Lymphocytic Leukemia: Clinical and Epidemiological: Poster
II
Sunday, December
12
5:00 – 7:00 p.m.
CT
Poster
|
Comparative
Effectiveness of Venetoclax Combinations vs Other Therapies Among
Patients with Newly Diagnosed Acute Myeloid Leukemia: Results from
the AML Real World Evidence (ARC) Initiative
|
Session: Acute
Myeloid Leukemias: Commercially Available Therapies, Excluding
Transplantation and Cellular Immunotherapies: Poster II
Sunday, December
12
5:00 – 7:00 p.m.
CT
Poster
|
Management and the
Use of Healthcare Resources in Patients with Chronic Lymphocytic
Leukemia (CLL) Initiating Venetoclax in Routine Clinical Practice
(DEVOTE) Across Canada
|
Session: Chronic
Lymphocytic Leukemia: Clinical and Epidemiological: Poster
III
Monday, December
13
5:00 – 7:00 p.m.
CT
Poster
Presentation
|
P17-132 AbbVie PMOS
VeRVe: Safety and Effectiveness of Venetoclax Therapy Subsequent to
BCRi Therapy Under Real-world Conditions in Austria, Germany and
Switzerland
|
Session: Chronic
Lymphocytic Leukemia: Clinical and Epidemiological: Poster
III
Monday, December
13
5:00 – 7:00 p.m.
CT
Poster
|
Debulking Before
Initiation of Venetoclax Therapy in Untreated Patients with Chronic
Lymphocytic Leukemia: Results from a Phase 3b Study
|
Session: Chronic
Lymphocytic Leukemia: Clinical and Epidemiological: Poster
III
Monday, December
13
5:00 – 7:00 p.m.
CT
Poster
|
Assessment of the
Clonal Dynamics of Acquired Mutations in Patients (pts) with
Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia (CLL)
Treated in the Randomized Phase 3 MURANO Trial Supports
Venetoclax+Rituximab (VenR) Fixed-Duration Combination Treatment
(tx)
|
Session: 1548 - 642.
Chronic Lymphocytic Leukemia: Clinical and Epidemiological: Poster
I
Saturday, December
11
4:30 - 6:30 p.m.
CT
Poster
|
Chronic Lymphocytic
Leukemia (CLL) Clonal Growth Rate is Influenced by Previous
Treatment (Tx) and is Slowed Down Following Venetoclax-Rituximab
(VenR): Results From a Minimal Residual Disease (MRD) Model From
the Randomized Phase 3 MURANO Trial
|
Session:
TBC
Saturday, December
11
4:30 - 6:30 p.m.
CT
Poster
|
Chronic Lymphocytic
Leukemia (CLL) Patients Quality of Life (QoL): A Cross-sectional
Analysis of the Italian Experience in the CHOICE Study During the
First Wave of the COVID-19 Pandemic
|
Abstract Publication
Only
|
COVID-19 Pandemic
Impact on Chronic Lymphocytic Leukemia (CLL) Patients' Preferences
Towards Therapies: The Italian Experience (Choice
Study).
|
Abstract Publication
Only
|
Lab-Based Response
Assessment Algorithm Recapitulates Investigator's Response
Assessment in the Phase 3 Bellini Trial
|
Abstract Publication
Only
|
Epcoritamab
|
Subcutaneous
Epcoritamab in Combination with R-CHOP in Patients with Previously
Untreated High-Risk Diffuse Large B-cell Lymphoma: Preliminary
Results from a Phase 1/2 Trial
|
Session: Aggressive
Lymphomas: Prospective Therapeutic Trials: Poster I
Saturday, December
11, 2021
4:30 – 6:30 p.m.
CT
Poster
|
Subcutaneous
Epcoritamab in Combination with R2 (Rituximab and Lenalidomide) in
Patients with Relapsed or Refractory Follicular Lymphoma:
Preliminary Results from a Phase 1/2 Trial
|
Session: Mantle Cell,
Follicular, and Other Indolent B Cell Lymphomas: Clinical and
Epidemiological: Poster III
Monday, December
13
5:00 – 7:00 p.m.
CT
Poster
|
Subcutaneous
Epcoritamab in Patients with Relapsed/Refractory Chronic
Lymphocytic Leukemia: Preliminary Results from the EPCORE CLL-1
Trial
|
Session: Chronic
Lymphocytic Leukemia: Clinical and Epidemiological: Poster
II
Sunday, December
12
5:00 – 7:00 p.m.
CT
Poster
|
Lemzoparlimab
|
Lemzoparlimab, a
Differentiated Anti-CD47 Antibody in Combination with Rituximab in
Relapsed and Refractory Non-Hodgkin's Lymphoma: Initial Clinical
Results
|
Session: Mantle Cell,
Follicular, and Other Indolent B Cell Lymphomas: Clinical and
Epidemiological: Poster III
Monday, December 13,
2021
6:00 – 8:00 p.m.
CT
Poster
|
ABBV-383
|
A Phase 1
First-in-Human Study of TNB-383B (ABBV-383), a BCMA x CD3
Bispecific T-Cell Redirecting Antibody, in Patients with
Relapsed/Refractory Multiple Myeloma
|
Session: Myeloma
and Plasma Cell Dyscrasias: Clinical-Prospective Therapeutic
Trials: Immune Therapy for Multiple Myeloma
Monday, December
13
6:30 p.m.
CT
Oral
|
The ASH 2021 Annual Meeting abstracts are available at:
https://www.hematology.org/meetings/annual-meeting/abstracts
*Use of venetoclax in multiple myeloma (MM) and myelodysplastic
syndromes (MDS) is not approved and its safety and efficacy
have not been evaluated by regulatory authorities.
*Epcoritamab is investigational and being developed through
Genmab and AbbVie as part of the companies' broad oncology
collaboration.
**Lemzoparlimab is investigational and being developed through a
comprehensive clinical development plan for hematologic
malignancies and solid tumor in collaboration with AbbVie and
I-Mab.
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 more 100
countries and has been used to treat more than 250,000 patients
worldwide across its approved indications.
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 31 leading cancer centers devoted to
patient care, research, and education, has recommended ibrutinib
(IMBRUVICA®) as a preferred regimen for first-line treatment of
CLL/SLL, with Category 1 status for previously untreated patients
without deletion 17p. Since January
2020, the NCCN Guidelines® have recommended IMBRUVICA® with
or without rituximab as a preferred regimen for the treatment of
relapsed/refractory MCL. Since September
2020, the NCCN guidelines have recommended IMBRUVICA® with
or without rituximab as a 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. There are more than 50 company
sponsored clinical trials, including 18 ongoing or completed Phase
3 studies, over 11 years evaluating efficacy and safety of
IMBRUVICA. 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 Information4
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. Venetoclax is being studied for new uses
including mantle cell lymphoma, Myelodysplastic syndromes and a
combination regimen of venetoclax + ibrutinib in chronic
lymphocytic leukemia.
Indication and Important Safety Information for VENCLEXTA®
(venetoclax) US5
Indication
VENCLEXTA is a BCL-2 inhibitor indicated:
- For the treatment of adult patients with chronic lymphocytic
leukemia (CLL) or small lymphocytic lymphoma (SLL). (1.1)
- In combination with azacitidine, or decitabine, or low-dose
cytarabine for the treatment of newly diagnosed acute myeloid
leukemia (AML) in adults 75 years or older, or who have
comorbidities that preclude use of intensive induction
chemotherapy.
Important Safety Information5
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 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.
Globally, prescribing information varies; refer to the
individual country product label for complete information.
About Epcoritamab
Epcoritamab is an investigational IgG1-bispecific antibody
created using Genmab's proprietary DuoBody technology. Genmab's
DuoBody-CD3 technology is designed to direct cytotoxic T cells
selectively to tumors to elicit an immune response towards
malignant cells. Epcoritamab is designed to simultaneously bind to
CD3 on T cells and CD20 on B cells and induces T cell mediated
killing of lymphoma B cells.6 CD20 is a clinically
validated therapeutic target, and is expressed on many B-cell
malignancies, including diffuse large B-cell lymphoma, follicular
lymphoma, mantle cell lymphoma and chronic lymphocytic
leukemia.7,8 Epcoritamab is being co-developed by Genmab
and AbbVie as part of the companies' broad oncology
collaboration.
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
_________________________________
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1 Genetics Home Reference. Isolated
growth hormone deficiency.
http://ghr.nlm.nih.gov/condition/isolated-growth-hormone-deficiency.
Accessed: November 2020.
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2 Turetsky, et al. Single cell
imaging of Bruton's Tyrosine Kinase using an irreversible
inhibitor. Scientific Reports. volume 4, Article number: 4782
(2014)
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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.
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4 IMBRUVICA U.S. Prescribing
Information.
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5
VENCLEXTA (venetoclax) [Package Insert]. North Chicago, IL.: AbbVie
Inc.
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6
Engelbert et al. "DuoBody-CD3xCD20 induces potent T-cell-mediated
killing of malignant B cells in preclinical models and provides
opportunities for subcutaneous dosing." EBioMedicine. 2020 Feb;52:
102625. doi: 10.1016/j.ebiom.2019.102625. Epub 2020 Jan 23. PMID:
31981978; PMCID: PMC6992935.
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7 Rafiq,
Sarwish, et al. "Comparative Assessment of Clinically Utilized
CD20-Directed Antibodies in Chronic Lymphocytic Leukemia Cells
Reveals Divergent NK Cell, Monocyte, and Macrophage Properties."
Journal of Immunology (Baltimore, Md. 1950), U.S. National Library
of Medicine, 15 Mar. 2013,
www.ncbi.nlm.nih.gov/pmc/articles/PMC3631574/.
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8 Singh,
Vijay, et al. "Development of Novel Anti-Cd20 Monoclonal Antibodies
and Modulation in Cd20 Levels on Cell Surface: Looking to Improve
Immunotherapy Response." Journal of Cancer Science & Therapy,
U.S. National Library of Medicine, Nov. 2015,
www.ncbi.nlm.nih.gov/pmc/articles/PMC4939752/.
|
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SOURCE AbbVie