NORTH CHICAGO, Ill.,
June 7, 2021 /PRNewswire/ -- AbbVie
(NYSE: ABBV) today announced new data from the Phase 2 CAPTIVATE
(PCYC-1142) study investigating IMBRUVICA® (ibrutinib)
in combination with VENCLEXTA®/VENCLYXTO®
(venetoclax), an all-oral, once-daily, chemotherapy-free,
fixed-duration investigational combination, for patients with
previously untreated chronic lymphocytic leukemia (CLL) or small
lymphocytic lymphoma (SLL) during an oral presentation at the
virtual 2021 American Society of Clinical Oncology (ASCO) Annual
Meeting (Abstract #7501). The ibrutinib and venetoclax cohort met
its primary endpoint of complete response (CR) rate of 56% (95% CI
48-64) among patients without del(17p), 70 years old or younger and
with 27.9 months of follow up. This rate was higher than the 37%
minimum meaningful rate study assumption (P<0.0001). The CR rate
was consistent across all patients in the study including high-risk
CLL patient groups. Furthermore, 24-month progression free survival
(PFS) and overall survival (OS) were 95% and 98%,
"We are encouraged by these promising results, which indicate
ibrutinib and venetoclax combined has the potential to serve as an
important chemotherapy-free, fixed-duration treatment option for
people living with CLL," said Dr. Paolo
Ghia, M.D., Ph.D., Professor of Medical Oncology at the
Università Vita-Salute San Raffaele and CAPTIVATE steering
committee member and investigator.
Ibrutinib plus venetoclax is an investigational fixed-duration
combination. Patients received 3 cycles of ibrutinib lead-in
followed by 12 cycles of ibrutinib + venetoclax (Ibr 420 mg/day PO;
Ven ramp up to 400 mg/day PO). At 27.9 months median duration of
follow-up in the fixed-duration cohort, complete response (CR) rate
was 56% without del(17p), and CR, including complete response with
incomplete marrow recovery (CRi), was 55% in the overall study
population and was consistent across high-risk subgroups.
Undetectable minimal residual disease (uMRD) was achieved in 77% of
patients in peripheral blood and 60% of patients in bone marrow.
The most common grade 3/4 adverse effects (AEs) were neutropenia
(33%), hypertension (6%) and neutrophil count decreased (5%). AEs
led to discontinuation of ibrutinib in 4% and venetoclax in 2% of
patients. The safety profile of the combination was generally
consistent with known AEs for each agent and no new safety signals
"Combining our novel therapies to deliver a new potential
treatment is an example of AbbVie's innovative approach to identify
options for difficult-to-treat blood cancers, like CLL," said
Mohamed Zaki, M.D., Ph.D., vice
president and global head of oncology development, AbbVie. "We are
proud to be leading in the development of this combination to
continue raising the standards of care for the blood cancer
This data builds on previously reported results from the Minimal
Residual Disease (MRD) cohort where undetectable uMRD was achieved
in over two-thirds of patients with 12 cycles of ibrutinib plus
venetoclax, and 30-month PFS rates were ≥95% irrespective of
subsequent randomized treatment (Wierda, ASH 2020).
CAPTIVATE data will also be presented at the European Hematology
Association's (EHA) congress taking place from June 9-17, 2021.
Additionally, there are other ongoing company-sponsored and
investigator-initiated trials exploring the potential of ibrutinib
and venetoclax in combination for CLL treatment, including the
Phase 3 GLOW study. Results from the ongoing GLOW study, assessing
the ibrutinib plus venetoclax combination in comparison to
chlorambucil plus obinutuzumab for first-line treatment of patients
with CLL or SLL (NCT03462719), will be presented at the upcoming
CLL is one of the two most common forms of
leukemia in adults and is a type of cancer that can develop from
cells in the bone marrow that later mature into certain white blood
cells (called lymphocytes).1 While these cancer cells
start in the bone marrow, they later spread into the blood. There
are approximately 195,129 people with CLL living in the United States with more than 21,000 newly
diagnosed patients in 2021.2,3 CLL is predominately a
disease of the elderly, with a median age at diagnosis of 70 years
and is more common among men than women.4
About the CAPTIVATE Study
The CAPTIVATE study fixed-duration cohort evaluated 159 patients
between the ages of 18 and 70 years old with CLL/SLL. Patients
received 3 cycles of ibrutinib lead-in followed by 12 cycles of
ibrutinib + venetoclax (Ibr 420 mg/day PO; Ven ramp up to 400
mg/day PO). High-risk features included del(17p)/TP53
mutation, 17%; del(11q), 18%; complex karyotype, 19%; and unmutated
IGHV, 56%. 147 (92%) and 149 (94%) patients completed planned
treatment with ibrutinib and venetoclax respectively. Median time
on study was 27.9 month (range, 0.8–33.2). FD cohort primary
endpoint was CR rate, including CR with incomplete marrow recovery
(CRi) in patients without del(17p). Key secondary endpoints were
objective response rate (ORR), duration of response, uMRD rate
(<10-4 by 8-color flow cytometry), PFS, OS, tumor lysis syndrome
(TLS) risk category reduction based on tumor burden shifted to
medium- or low-risk after ibrutinib lead-in therapy and AEs.
The CAPTIVATE study MRD cohort evaluated 164 patients between
the ages of 18 and 70 years old with previously untreated CLL/SLL.
Patients received 3 cycles of ibrutinib lead-in followed by 12
cycles of ibrutinib + venetoclax (Ibr 420 mg/day PO; Ven ramp-up to
400 mg/day PO). Patients with confirmed uMRD (defined as uMRD
serially over ≥3 cycles, and in both PB and BM) after 12 cycles of
ibrutinib + venetoclax were randomized 1:1 to receive double-blind
treatment with placebo or ibrutinib during a 13th cycle
of ibrutinib and venetoclax combined. Patients who did not meet the
definition of confirmed uMRD were randomized 1:1 to receive
open-label treatment with ibrutinib or continued ibrutinib +
venetoclax. Primary endpoint was 1-year DFS rate in the confirmed
uMRD patients randomized to placebo vs ibrutinib; DFS was defined
as survival without progression or MRD relapse (which was defined
as an MRD level of 10-2). Key secondary endpoints were rates of
uMRD (<10-4 by 8-color flow cytometry), response per iwCLL,
adverse events (AEs), as well as progression-free survival (PFS).
The depth of response achieved with this regimen is reflected in
the 30-month progression-free survival (PFS) rate of ~95% across
all treated patients, including the subset receiving placebo after
the fixed-duration treatment. The safety profile of the combination
was generally consistent with known adverse events for ibrutinib
and venetoclax individually and no new safety signals emerged.
About IMBRUVICA ® (Ibrutinib)
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.5,6 By blocking BTK, IMBRUVICA may help move
abnormal B cells out of their nourishing environments in the lymph
nodes, bone marrow, and other organs.7
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.8
IMBRUVICA is now approved in more than 100 countries and
has been used to treat more than 230,000 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,
*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 8
Before taking IMBRUVICA®, tell your healthcare
provider about all of your medical conditions, including if
- 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
- 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
- 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
- If you take too much IMBRUVICA® call your healthcare
provider or go to the nearest hospital emergency room right
What should I avoid while taking
- 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® may cause serious side effects,
- 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
- 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
- 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
- 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)
- muscle and bone pain
The most common side effects of IMBRUVICA® in
adults with cGVHD include:
- mouth sores (stomatitis)
- muscle spasms
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
General information about the safe and effective use of
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
Please click here for full Prescribing Information.
(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 Information9
the most important information I should know about
VENCLEXTA can cause serious side effects,
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
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
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
- 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
- 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 can cause serious side effects,
- 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
- 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
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
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
You are encouraged to report side effects of
prescription drug to the
FDA. Visit www.fda.gov/medwatch or call
If you cannot afford your medication, contact
The full U.S. prescribing information, including Medication
Guide, for VENCLEXTA® can be found here
Indication and Important
VENCLYXTO® (venetoclax) EU Safety
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.
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
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
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
Live vaccines should not be administered during treatment or
thereafter until B-cell recovery.
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
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®.
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
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
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
For patients with severe (Child-Pugh C) hepatic impairment, a
dose reduction of at least 50% throughout treatment is
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
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
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news release are, or may be considered, forward-looking statements
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1 American Society of Hematology. Leukemia.
2 IMS Database [Data on File].
3 National Cancer Institute. Cancer Stat Facts:
Leukemia - Chronic Lymphocytic Leukemia (CLL).
4 Shanafelt, et al. Age at Diagnosis and the Utility of
Prognostic Testing in Patients with Chronic Lymphocytic Leukemia
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