FDA Gives Full Approval to Venclexta

FDA has granted full approval for AbbVie and Roche’s Venclexta (venetoclax) in combination with azacitidine, or decitabine, or low-dose cytarabine for treating newly diagnosed acute myeloid leukemia in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. Venclexta was granted an accelerated approval 11/2018 for the regimen.

Approval is based on data from two Phase 3 studies, VIALE-A and VIALE-C. Results from the VIALE-A study showed that Venclexta plus azacitidine significantly reduced the risk of death by 34% (overall survival) compared to azacitidine alone (median 14.7 months vs. 9.6 months, Roche says. In the VIALE-C study, 27% of people treated with Venclexta plus low-dose cytarabine achieved a complete response (median duration of 11.1 months) versus a 7.4% complete response in people treated with low-dose cytarabine alone (median duration of 8.3 months), it says.