The phase III VIALE-A study demonstrated that Venclexta in combination with azacitidine, a hypomethylating agent, showed a statistically significant improvement in overall survival in people with previously untreated acute myeloid leukemia who were ineligible for intensive induction chemotherapy, compared to azacitidine alone.
The trial, sponsored by Genentech, a member of the Roche Group, met its dual primary endpoints of overall survival and composite complete remission rate.
FDA previously granted Venclexta accelerated approval in combination with azacitidine, or decitabine, or low-dose cytarabine for the treatment of people with newly-diagnosed AML who are 75 years or older, or for those ineligible for intensive induction chemotherapy due to coexisting medical conditions, based on response rates from the M14-358 and M14-387 studies.
Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory studies. Venclexta has also been granted five Breakthrough Therapy Designations by the FDA, including two for previously untreated AML.
Venclexta is being developed by AbbVie and Genentech. It is jointly commercialized by the companies in the United States and commercialized by AbbVie outside of the United States.
