South San Francisco, California — February 20, 2026 — Leads & Copy —
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced that the U.S. Food and Drug Administration (FDA) has approved Venclexta® (venetoclax) plus acalabrutinib for previously untreated adults with chronic lymphocytic leukemia (CLL). The approval is based on results from the Phase III AMPLIFY study.
According to Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development, the approval represents an important step forward for people newly diagnosed with CLL. Garraway stated that as the first and only all-oral, fixed-duration regimen, this approval gives patients the opportunity to spend more time off therapy and underscores the ongoing evolution of Venclexta-based approaches, offering clinicians another way to individualize first-line care.
The Phase III AMPLIFY study demonstrated that Venclexta plus acalabrutinib was superior to chemoimmunotherapy, reducing the risk of disease progression or death by 35% (HR 0.65; 95% CI: 0.49-0.87; p=0.0038). At a median follow-up of 42.6 months, median progression-free survival was not reached for the combination regimen (95% CI: 51.1 months, not reached) versus 47.6 months (95% CI: 43.3 months, not reached) for chemoimmunotherapy. The safety profile of Venclexta plus acalabrutinib is consistent with the known safety profile of each individual therapy alone. In chronic lymphocytic leukemia or small lymphocytic lymphoma, the most common adverse reactions (≥20%) for Venclexta when given in combination with acalabrutinib were neutropenia, headache, diarrhea, musculoskeletal pain, and COVID-19. The most common serious adverse reactions (≥2%) in patients receiving Venclexta plus acalabrutinib were COVID-19, including COVID-19 pneumonia (9%), second primary malignancies (2.7%), and neutropenia (2.1%).
CLL is one of the most common forms of leukemia in adults. While outcomes have improved in recent years, patients often face long treatment durations and ongoing disease management challenges.
Dr. John M. Burke, M.D., Hematology and Oncology, Rocky Mountain Cancer Centers, noted that fixed-duration regimens are a critical component of today’s CLL management. He added that having an all-oral option with a defined end date can provide patients with a clear and predictable treatment timeline and that this approval provides an important new option for eligible patients to achieve durable responses in the first line.
The AMPLIFY study (NCT05197192) is an AstraZeneca-sponsored global, multi-center, open-label, Phase III study evaluating fixed-duration Venclexta® (venetoclax) plus acalabrutinib, alone or combined with Gazyva® (obinutuzumab), compared to investigator’s choice of chemoimmunotherapy in patients with previously untreated CLL without 17p deletion or TP53 mutation. In AMPLIFY, patients were randomized 1:1:1 to receive either Venclexta plus acalabrutinib, Venclexta plus acalabrutinib with Gazyva for a fixed duration, or chemoimmunotherapy. Both investigational arms using 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. Interim results show the regimen significantly improved progression-free survival versus chemoimmunotherapy.
Chronic lymphocytic leukemia (CLL) is a slow-growing cancer in the blood and bone marrow and is the most common type of leukemia in the U.S., with an estimated 22,760 new cases in 2026. Although signs of CLL may disappear for a while after initial treatment, many people require additional treatment due to the return of cancerous cells.
Venclexta is a first-in-class targeted medicine designed to bind selectively and inhibit the B-cell lymphoma-2 (BCL-2) protein. In some blood cancers and other tumors, BCL-2 builds up and prevents cancer cells from dying or self-destructing, a process called apoptosis. Venclexta blocks the BCL-2 protein and works to help restore the process of apoptosis.
Venclexta is being developed by AbbVie and Genentech, a member of the Roche Group. It is jointly commercialized by the companies in the U.S. and commercialized by AbbVie outside of the U.S. Together, the companies are committed to BCL-2 research and to studying Venclexta in clinical trials across several types of blood cancers. Venclexta is approved in more than 80 countries, including the U.S.
Genentech is committed to helping patients get the medicine their doctor prescribed and offers patient support services for those who qualify. For more information, call 866-4ACCESS/866-422-2377 or visit http://www.Genentech-Access.com.
Gazyva® (obinutuzumab) is a humanized monoclonal antibody designed with a Type II anti-CD20 region, for direct B cell death and a glycoengineered Fc region, for higher binding affinity and increased antibody-dependent cellular cytotoxicity (ADCC). CD20 is a protein found on certain types of B cells. Gazyva is approved in 100 countries for various types of hematological cancers. Please visit https://www.GAZYVA.com for the accompanying full Prescribing Information, including BOXED WARNINGS, for additional Important Safety Information.
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Founded 50 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.
Source: Genentech
