{"id":62676,"date":"2026-02-20T10:06:00","date_gmt":"2026-02-20T09:06:00","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/fda-approves-genentechs-venclexta-plus-acalabrutinib-combination-regimen-for-previously-untreated-chronic-lymphocytic-leukemia\/"},"modified":"2026-02-20T10:06:00","modified_gmt":"2026-02-20T09:06:00","slug":"fda-approves-genentechs-venclexta-plus-acalabrutinib-combination-regimen-for-previously-untreated-chronic-lymphocytic-leukemia","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/fda-approves-genentechs-venclexta-plus-acalabrutinib-combination-regimen-for-previously-untreated-chronic-lymphocytic-leukemia\/","title":{"rendered":"FDA Approves Genentech\u2019s Venclexta\u00ae Plus Acalabrutinib Combination Regimen for Previously Untreated Chronic Lymphocytic Leukemia"},"content":{"rendered":"
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\n\u2013 First and only all-oral, fixed-duration regimen designed to provide CLL patients with the potential to experience time off treatment \u2013<\/i><\/p>\n

\n\u2013 Approval expands Genentech\u2019s fixed-duration portfolio by providing eligible first-line patients another option alongside the established Venclexta plus Gazyva regimen \u2013<\/i><\/p>\n

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved the combination regimen of Venclexta\u00ae <\/sup>(venetoclax) plus acalabrutinib for the treatment of previously untreated adults with chronic lymphocytic leukemia (CLL), based on results from the Phase III AMPLIFY study.<\/p>\n

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\n\u201cToday\u2019s approval represents an important step forward for people newly diagnosed with chronic lymphocytic leukemia,\u201d said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. \u201cAs the first and only all-oral, fixed-duration regimen, this approval gives patients the opportunity to spend more time off therapy. This milestone underscores the ongoing evolution of Venclexta-based approaches, offering clinicians another way to individualize first-line care.\u201d<\/p>\n

\nThe approval of Venclexta in combination with acalabrutinib is based on results from the Phase III AMPLIFY study. The study demonstrated that Venclexta plus acalabrutinib was superior to chemoimmunotherapy. Study results showed the combination regimen reduced the risk of disease progression or death by 35% versus chemoimmunotherapy (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 (\u226520%) for Venclexta when given in combination with acalabrutinib were neutropenia, headache, diarrhea, musculoskeletal pain, and COVID-19. The most common serious adverse reactions (\u22652%) in patients receiving Venclexta plus acalabrutinib were COVID-19, including COVID-19 pneumonia (9%), second primary malignancies (2.7%), and neutropenia (2.1%).<\/p>\n

\nCLL 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.<\/p>\n

\n\u201cFixed-duration regimens are a critical component of today\u2019s chronic lymphocytic leukemia management,\u201d said Dr. John M. Burke, M.D., Hematology and Oncology, Rocky Mountain Cancer Centers. \u201cHaving an all-oral option with a defined end date can provide patients with a clear and predictable treatment timeline. This approval provides an important new option for eligible patients to achieve durable responses in the first line.\u201d<\/p>\n

\nGenentech is committed to helping patients get the medicine their doctor prescribed. For people who qualify, Genentech offers patient support services. For more information, please call 866-4ACCESS\/866-422-2377 or http:\/\/www.Genentech-Access.com<\/a>.<\/p>\n

\nAbout the AMPLIFY study<\/b><\/p>\n

\nThe AMPLIFY study (NCT05197192<\/a>) is an AstraZeneca-sponsored global, multi-center, open-label, Phase III study evaluating fixed-duration Venclexta\u00ae<\/sup> (venetoclax) plus acalabrutinib, alone or combined with Gazyva\u00ae<\/sup> (obinutuzumab), compared to investigator\u2019s choice of chemoimmunotherapy in patients with previously untreated chronic lymphocytic leukemia (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.<\/p>\n

\nAbout CLL<\/b><\/p>\n

\nChronic lymphocytic leukemia (CLL) is a slow-growing cancer in the blood and bone marrow. It is the most common type of leukemia in the U.S., with an estimated number of 22,760 new cases of CLL 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.<\/p>\n

\nAbout Venclexta\u00ae <\/sup>(venetoclax)<\/b><\/p>\n

\nVenclexta 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.<\/p>\n

\nVenclexta 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.<\/p>\n

\nIndication<\/b><\/p>\n

\nVENCLEXTA is a prescription medicine used:<\/p>\n