FDA Grants Full Approval For Genentech’s Acute Myeloid Leukemia Medicine Under the FDA’s Real-Time Oncology Review Pilot Program And Project Orbis Initiative
October 21st, 2020
On October 16, 2020, the FDA granted full approval of Venclexta® (venetoclax) in combination with azacitidine, 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. Venclexta (venetoclax) was previously granted provisional approval in this setting under the FDA’s accelerated approval program.
News in brief
- The approval is supported by data from Phase III confirmatory trials, VIALE-A and VIALE-C.
- The supplemental New Drug Applications were approved under the FDA’s Real-Time Oncology Review pilot program and Project Orbis initiative.
- AML is the most common type of aggressive leukemia in adults and has the lowest survival rate for all types of leukemia.
Supporting Information
“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. 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.”