Full FDA Approval for Venclexta Combinations for Acute Myeloid Leukemia
The US FDA has granted its full approval to Venclexta (venetoclax) for newly diagnosed acute myeloid leukemia (AML) in adults 75 years or older who are unfit for intensive induction chemotherapies.
The approval is based on the results of clinical trial Phase lll VIALE-A & VIALE-C. VIALE-A trial demonstrated a significant reduction in the risk of death and higher rates of complete remissions upon administration of Venclexta in a combination of azacytidine as compared to azacytidine alone. The drug has already bagged the accelerated FDA approval in this setting, and with the recent...
