On October 16, 2020, the FDA granted full approval to venetoclax (Venclexta; AbbVie and Genentech) in combination with azacitidine, decitabine, or low-dose cytarabine for newly diagnosed acute myeloid leukemia (AML) in adults aged ≥75 years or who have comorbidities precluding intensive induction chemotherapy.
Venetoclax was initially granted accelerated approval for this indication on November 21, 2018, based on the results of 2 clinical trials of patients with newly diagnosed AML who were aged ≥75 years or who had comorbidities that precluded the use of intensive induction chemotherapy: M14-358, a trial evaluating venetoclax in combination with azacitidine (N = 67) or decitabine (N = 13), and M14-387, a trial of venetoclax and low-dose cytarabine (N = 61). Efficacy was established based on the rate of complete remission and duration of complete remission in these trials. The more recent full approval was based on efficacy data from 2 phase 3 clinical trials (VIALE-A and VIALE-C). Updated results from additional phase 1/2 studies of venetoclax in patients with newly diagnosed AML were also included in the FDA submissions as supporting data.
“Today’s full approval is supported by the significant results that showed that Venclexta in combination with azacitidine extended overall survival for people with newly diagnosed acute myeloid leukemia who cannot tolerate intensive induction chemotherapy,” said Levi Garraway, MD, PhD, Chief Medical Officer and Head of Global Product Development at Genentech, in a recent press release. “We are very pleased that this application was reviewed under the FDA’s Real-Time Oncology Review pilot and Project Orbis initiative, helping to bring this treatment option more rapidly to patients in the United States and other countries.”