- US FDA announces full approval to AbbVie's (NYSE:ABBV) VENCLEXTA (venetoclax) in combination with azacitidine, or decitabine, or low-dose cytarabine for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults who are age 75 years or older, or who have comorbidities that preclude the use of intensive induction chemotherapy.
- The approval is supported by data from the Phase 3 VIALE-A (M15-656) and VIALE-C (M16-043) studies, and updated data from the Phase 1b M14-358 and the Phase 1/2 M14-387 studies.
- The FDA previously granted accelerated approval to VENCLEXTA for this indication in 2018.
- Venetoclax 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.