AbbVie (NYSE:ABBV) announced on February 20, 2026, that the U.S. Food and Drug Administration (FDA), has approved the combination of VENCLEXTA (venetoclax) and acalabrutinib for adult patients with previously untreated chronic lymphocytic leukemia (CLL).
This landmark approval establishes the first and only all-oral, fixed-duration regimen for frontline CLL, offering patients a highly effective treatment without the need for intravenous infusions or indefinite therapy.
The FDA’s decision was based on results from the pivotal Phase 3 AMPLIFY trial, which evaluated the doublet of Venclexta and acalabrutinib (AV) against standard chemoimmunotherapy.
Data showed that the AV regimen reduced the risk of disease progression or death by 35% (HR 0.65).
At a median follow-up of 42.6 months, the median progression-free survival (PFS) for the combination had not yet been reached, compared to 47.6 months for the chemotherapy arm.
Venclexta is a BCL-2 inhibitor developed by AbbVie and Genentech (a member of the Roche Group), while acalabrutinib (Calquence) is a second-generation BTK inhibitor developed by AstraZeneca.
The approval significantly expands AbbVie’s oncology portfolio, providing an oral alternative to the established Venclexta plus Gazyva (obinutuzumab) infusion regimen.