Health
U.S. Food and Drug Administration (FDA) Approves Combination Treatment of VENCLEXTA® (venetoclax) and Acalabrutinib for Previously Untreated Patients With Chronic Lymphocytic Leukemia (CLL)
AbbVie (NYSE: ABBV) today announced 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
About this update from Abbvie Inc.
[{"type":"list","items":[{"val":[{"type":"text","content":"First all-oral, fixed-duration combination regimen approved for previously untreated patients with CLL ","length":107,"tagName":"p"}]},{"val":[{"type":"text","content":"Approval supported by data from the Phase 3 AMPLIFY trial","length":57,"tagName":"p"}]},{"val":[{"type":"text","content":"Regimen offers another option for the potential of time off treatment, marking a meaningful advance in long-term disease management","length":131,"tagName":"p"}]}],"tagName":"ul","bulletedList":true,"length":295,"olType":false},{"type":"text","content":"NORTH CHICAGO, Ill., Feb. 20, 2026 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced 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","length":429,"tagName":"p"},{"type":"text","content":"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.","length":421,"tagName":"p"},{"type":"text","content":""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."","length":462,"tagName":"p"},{"type":"text","content":"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...