NORTH CHICAGO, Ill.,
July 21, 2021 /PRNewswire/
-- AbbVie (NYSE: ABBV) announced today that the U.S. Food and
Drug Administration (FDA) granted a Breakthrough Therapy
Designation (BTD) to venetoclax (VENCLEXTA®) in
combination with azacitidine for the potential treatment of adult
patients with previously untreated intermediate-, high- and very
high-risk myelodysplastic syndromes (MDS) based on revised
International Prognostic Scoring System (IPSS-R). A BTD is intended
to expedite the development and review of medications to treat a
serious medical condition and is granted when preliminary clinical
evidence indicates the investigational therapy may demonstrate
substantial improvement over existing therapies.1 This
marks the sixth BTD granted to venetoclax.
MDS are a group of diverse bone marrow disorders in which the
bone marrow does not produce enough healthy blood
cells.2 Patients living with MDS may experience
symptoms such as infection, anemia, spontaneous bleeding, and easy
bruising. Roughly 10,000 patients in the US are diagnosed with MDS
each year3 and around 30 percent of those patients will
progress to acute myeloid leukemia (AML). Although MDS can
occur at any age, it is most commonly found in patients aged 60 and
older.4
"MDS is a devastating diagnosis - not only does it have the
potential to greatly impact patients' quality of life, but 30
percent of patients will also progress to AML," said Jalaja Potluri, executive medical director,
oncology, AbbVie. "This Breakthrough Therapy Designation
underscores the need for more treatment options for these patients
and the utility of venetoclax to potentially treat different forms
of blood cancer."
This designation is supported by data from the Phase
1b M15-531 study. In addition to the
Phase Ib M15-531 study, venetoclax is being investigated in
combination with azacitidine for the treatment of MDS in the Phase
Ib M15-522 study in patients with relapsed or refractory disease,
and the Phase 3 randomized VERONA study in patients with newly
diagnosed higher-risk MDS.
VENCLEXTA 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.
About VENCLEXTA®
(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.
Uses of VENCLEXTA® (venetoclax) in US
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.
It is not known if VENCLEXTA is safe and effective in
children.
Important VENCLEXTA® (venetoclax) US Safety
Information
US VENCLEXTA® Important Safety
Information
What is the most important information I should know about
VENCLEXTA?
VENCLEXTA can cause serious side effects,
including:
Tumor lysis syndrome (TLS). TLS is caused by the fast
breakdown of cancer cells. TLS can cause kidney failure, the need
for dialysis treatment, and may lead to death. Your healthcare
provider will do tests to check your risk of getting TLS before you
start taking VENCLEXTA. You will receive other medicines
before starting and during treatment with VENCLEXTA to help reduce
your risk of TLS. You may also need to receive intravenous (IV)
fluids into your vein. Your healthcare provider will do blood tests
to check for TLS when you first start treatment and during
treatment with VENCLEXTA. It is important to keep your
appointments for blood tests. Tell your healthcare provider right
away if you have any symptoms of TLS during treatment with
VENCLEXTA, including fever, chills, nausea, vomiting,
confusion, shortness of breath,
seizures, irregular heartbeat, dark or cloudy urine, unusual
tiredness, or muscle or joint pain.
Drink plenty of water during treatment with VENCLEXTA to help
reduce your risk of getting TLS.
Drink 6 to 8 glasses (about 56 ounces total) of water each day,
starting 2 days before your first dose, on the day of your first
dose of VENCLEXTA, and each time your dose is
increased.
Your healthcare provider may delay, decrease your dose, or stop
treatment with VENCLEXTA if you have side effects. When
restarting VENCLEXTA after stopping for 1 week or longer, your
healthcare provider may again check for your risk of TLS and
change your dose.
Who should not take VENCLEXTA?
Certain medicines must not be taken when you first start taking
VENCLEXTA and while your dose is being slowly increased because of
the risk of increased TLS.
- Tell your healthcare provider about all the medicines you
take, including prescription and over-the counter medicines,
vitamins, and herbal supplements. VENCLEXTA and other medicines may
affect each other causing serious side effects.
- Do not start new medicines during treatment with VENCLEXTA
without first talking with your healthcare provider.
Before taking VENCLEXTA, tell your healthcare provider
about all of your medical conditions, including if
you:
- have kidney or liver problems.
- have problems with your body salts or electrolytes, such as
potassium, phosphorus, or calcium.
- have a history of high uric acid levels in your blood or
gout.
- are scheduled to receive a vaccine. You should not receive a
"live vaccine" before, during, or after treatment with VENCLEXTA,
until your healthcare provider tells you it is okay. If you are not
sure about the type of immunization or vaccine, ask your healthcare
provider. These vaccines may not be safe or may not work as well
during treatment with VENCLEXTA.
- are pregnant or plan to become pregnant. VENCLEXTA may harm
your unborn baby. If you are able to become pregnant, your
healthcare provider should do a pregnancy test before you start
treatment with VENCLEXTA, and you should use effective birth
control during treatment and for at least 30 days after the last
dose of VENCLEXTA. If you become pregnant or think you are
pregnant, tell your healthcare provider right away.
- are breastfeeding or plan to breastfeed. It is not known if
VENCLEXTA passes into your breast milk. Do not breastfeed during
treatment with VENCLEXTA and for 1 week after the last dose.
What should I avoid while taking VENCLEXTA?
You should not drink grapefruit juice or eat
grapefruit, Seville oranges (often used in marmalades),
or starfruit while you are taking VENCLEXTA. These products
may increase the amount of VENCLEXTA in your blood.
What are the possible side effects of
VENCLEXTA?
VENCLEXTA can cause serious side effects,
including:
- Low white blood cell counts (neutropenia). Low
white blood cell counts are common with VENCLEXTA, but can also be
severe. Your healthcare provider will do blood tests to check your
blood counts during treatment with VENCLEXTA and may pause
dosing.
- Infections. Death and serious infections such as
pneumonia and blood infection (sepsis) have happened during
treatment with VENCLEXTA. Your healthcare provider will closely
monitor and treat you right away if you have a fever or any signs
of infection during treatment with VENCLEXTA.
Tell your healthcare provider right away if you have a fever or
any signs of an infection during treatment with
VENCLEXTA.
The most common side effects of VENCLEXTA when used in
combination with obinutuzumab or rituximab or alone in people with
CLL or SLL include low white blood cell counts; low
platelet counts; low red blood cell counts; diarrhea; nausea; upper
respiratory tract infection; cough; muscle and joint pain;
tiredness; and swelling of your arms, legs, hands, and
feet.
The most common side effects of VENCLEXTA in combination
with azacitidine or decitabine or low-dose cytarabine in people
with AML include nausea; diarrhea; low platelet count;
constipation; low white blood cell count; fever with low white
blood cell count; tiredness; vomiting; swelling of arms, legs,
hands, or feet; fever; infection in lungs; shortness of breath;
bleeding; low red blood cell count; rash; stomach (abdominal) pain;
infection in your blood; muscle and joint pain; dizziness; cough;
sore throat; and low blood pressure.
VENCLEXTA may cause fertility problems in males. This may affect
your ability to father a child. Talk to your healthcare provider if
you have concerns about fertility.
These are not all the possible side effects of
VENCLEXTA. Call your doctor for medical advice about side
effects.
You are encouraged to report side effects of
prescription drug to the FDA.
Visit www.fda.gov/medwatch or call
1-800-FDA-1088.
If you cannot afford your medication, contact
genentech-access.com/patient/brands/venclexta for
assistance.
The full U.S. prescribing information, including Medication
Guide, for VENCLEXTA® can be
found here.
About AbbVie in Oncology
At AbbVie, we are committed
to transforming standards of care for multiple blood cancers while
advancing a dynamic pipeline of investigational therapies across a
range of cancer types. Our dedicated and experienced team joins
forces with innovative partners to accelerate the delivery of
potentially breakthrough medicines. We are evaluating more than 20
investigational medicines in over 300 clinical trials across some
of the world's most widespread and debilitating cancers. As we work
to have a remarkable impact on people's lives, we are committed to
exploring solutions to help patients obtain access to our cancer
medicines. For more information, please
visit http://www.abbvie.com/oncology.
About AbbVie
AbbVie's mission is to discover and
deliver innovative medicines that solve serious health issues today
and address the medical challenges of tomorrow. We strive to have a
remarkable impact on people's lives across several key therapeutic
areas: immunology, oncology, neuroscience, eye care, virology,
women's health and gastroenterology, in addition to products and
services across its Allergan Aesthetics portfolio. For more
information about AbbVie, please visit us at www.abbvie.com.
Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Forward-Looking Statements
Some statements in this
news release are, or may be considered, forward-looking statements
for purposes of the Private Securities Litigation Reform Act of
1995. The words "believe," "expect," "anticipate," "project" and
similar expressions, among others, generally identify
forward-looking statements. AbbVie cautions that these
forward-looking statements are subject to risks and uncertainties
that may cause actual results to differ materially from those
indicated in the forward-looking statements. Such risks and
uncertainties include, but are not limited to, failure to realize
the expected benefits from AbbVie's acquisition of Allergan plc
("Allergan"), failure to promptly and effectively integrate
Allergan's businesses, competition from other products, challenges
to intellectual property, difficulties inherent in the research and
development process, adverse litigation or government action,
changes to laws and regulations applicable to our industry and the
impact of public health outbreaks, epidemics or pandemics, such as
COVID-19. Additional information about the economic, competitive,
governmental, technological and other factors that may affect
AbbVie's operations is set forth in Item 1A, "Risk Factors," of
AbbVie's 2020 Annual Report on Form 10-K, which has been filed with
the Securities and Exchange Commission, as updated by its
subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no
obligation to release publicly any revisions to forward-looking
statements as a result of subsequent events or developments, except
as required by law.
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1 U.S. Food and Drug Administration.
Breakthrough Therapy.
https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/breakthrough-therapy.
Accessed July 19, 2021.
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2 MDS
Foundation. What is MDS?.
https://www.mds-foundation.org/what-is-mds/. Accessed July 14,
2021.
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3
Cancer.Net. Myelodysplastic Syndromes – MDS: Statistics.
https://www.cancer.net/cancer-types/myelodysplastic-syndromes-mds/statistics#:~:text=Approximately%2010%2C000%20people%20in%20the,year%20is%20likely%20to%20increase.
Accessed July 19, 2021.
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4 American
Cancer Society. What are Myelodysplastic Syndromes?.
https://www.cancer.org/cancer/myelodysplastic-syndrome/about/what-is-mds.html.
Accessed July 14, 2021.
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SOURCE AbbVie