On February 20, 2026 AbbVie (NYSE: ABBV) reported that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for the combination regimen of VENCLEXTA (venetoclax) and acalabrutinib for the treatment of previously untreated adult patients with chronic lymphocytic leukemia (CLL). The approval is supported by data from the Phase 3 AMPLIFY trial.1

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This milestone updates the treatment of CLL in the first-line setting, establishing the VENCLEXTA and acalabrutinib combination as the first and only all-oral, fixed-duration regimen for previously untreated patients. The regimen supports current standards of care by offering patients the potential for time off treatment and giving providers a new, targeted option that combines two classes of oral medications for CLL.

"This FDA approval marks a significant milestone for AbbVie and, more importantly, for people living with CLL," said Svetlana Kobina, vice president, global medical affairs, oncology, AbbVie. "As the first and only all-oral, fixed-duration combination regimen for previously untreated patients, the VENCLEXTA plus acalabrutinib approval expands choice and flexibility for patients and providers navigating complex treatment decisions in CLL."

CLL is one of the 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).2 While outcomes have improved in recent years, patients often face long treatment durations and ongoing disease management challenges.

"With the FDA approval of the combination of venetoclax and acalabrutinib for use as a front-line therapy in CLL, patients in the USA now have an all oral, time-limited option that can be important for many in choosing their treatment," said Dr. Brian Koffman, co-founder and chief medical officer emeritus, CLL Society. "CLL Society is pleased to see the number of choices available for patients growing."

About the AMPLIFY Study
AMPLIFY is an AstraZeneca-sponsored, global, multi-center Phase 3 trial evaluating VENCLEXTA plus acalabrutinib alone or combined with obinutuzumab versus chemoimmunotherapy (investigator’s choice of fludarabine-cyclophosphamide-rituximab [FCR] or bendamustine-rituximab [BR]) in patients with previously untreated CLL without del(17p) or TP53 mutation.1 VENCLEXTA plus acalabrutinib were administered for a fixed duration of 14 cycles, each consisting of 28 days, while chemoimmunotherapy was administered for six cycles according to regimens. VENCLEXTA was started on cycle 3 of 14 with a 5-week ramp-up schedule.

Results from the AMPLIFY study showed that the fixed-duration combination regimen of VENCLEXTA and acalabrutinib was superior to FCR/BR chemoimmunotherapy. Study results showed the combination regimen of VENCLEXTA and acalabrutinib reduced the risk of disease progression or death by 35% versus chemoimmunotherapy (HR 0.65; 95% CI: 0.49-0.87; p=0.0038). Median progression-free survival (PFS) was not reached versus 47.6 months for chemoimmunotherapy. The safety profile of the VENCLEXTA and acalabrutinib combination regimen is consistent with the known safety profile of each individual therapy alone. In CLL/SLL, the most common adverse reactions (≥20%) for VENCLEXTA when given in combination with acalabrutinib are neutropenia, headache, diarrhea, musculoskeletal pain, and COVID-19. The most common serious adverse reactions (≥2%) in patients receiving V+A were COVID-19, including COVID-19 pneumonia (9%), second primary malignancies (2.7%), and neutropenia (2.1%). In patients treated with VENCLEXTA plus acalabrutinib, the incidence of tumor lysis syndrome was 0.3%. No new safety signals were observed in the AMPLIFY study.3

About VENCLEXTA (venetoclax)
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 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. Venetoclax is approved in more than 80 countries, including the U.S.

VENCLEXTA (venetoclax) U.S. Uses and Important Safety Information4
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.

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 and during treatment with VENCLEXTA. It is important to keep your appointments for blood tests. Tell your healthcare provider right away if you get 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 get symptoms of TLS. When restarting VENCLEXTA after stopping for 1 week or longer, your healthcare provider may check again for your risk of TLS and change your dose.

Who should not take VENCLEXTA?
Patients taking certain medicines during the beginning of VENCLEXTA (when the dose is being slowly increased) are at increased risk of 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.
Females who are able to become pregnant:
– Your healthcare provider should do a pregnancy test before you start treatment with VENCLEXTA.
– 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 during treatment with 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). Your healthcare provider will do blood tests to check your blood count during treatment with VENCLEXTA and may pause dosing of VENCLEXTA or give you medicines to help treat your neutropenia if it is severe.
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 get a fever or any signs of infection during treatment with VENCLEXTA.
Tell your healthcare provider right away if you get a fever or any signs of an infection during treatment with VENCLEXTA.

The most common side effects of VENCLEXTA when used in combination with acalabrutinib in people with CLL or SLL include low white blood cell count, headache, diarrhea, muscle and bone pain, and COVID-19.

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 count; low platelet count; low red blood cell count; 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.

Your healthcare provider may temporarily stop VENCLEXTA treatment, decrease your dose, or completely stop treatment if you get severe side effects.

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 drugs 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.

(Press release, AbbVie, FEB 20, 2026, View Source [SID1234662824])