Roche announced that the U.S. Food and Drug Administration (FDA) has granted full approval of Venclexta (venetoclax) in combination with azacitidine, or decitabine, or low-dose cytarabine (LDAC) for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy, according to a press release.
Venclexta was previously granted provisional approval in this setting under the FDA’s accelerated approval program in November 2018.
The approval is primarily based on the results of two phase III studies, VIALE-A and VIALE-C. Results of the VIALE-A study, which were published in the New England Journal of Medicine in August 2020, showed Venclexta plus azacitidine significantly reduced the risk of death by 34 percent, compared to azacitidine alone. People treated with Venclexta plus azacitidine had significantly higher rates of complete remission, or 37 percent, compared to 18 percent in people treated with azacitidine alone.
For the VIALE-C study, the approval was based on the rate and duration of CR. Twenty-seven percent of people treated with Venclexta plus LDAC achieved a complete remission, compared 7.4 percent of people treated with LDAC alone.
Venclexta 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 commercialized by AbbVie, under the brand name Venclyxto outside of the United States.
