MHRA approves venetoclax for treatment of patients with newly diagnosed acute myeloid leukaemia who are ineligible for intensive chemotherapy

Approval is based on phase III VIALE-A study which demonstrated combination of venetoclax and azacitidine was linked to a statistically significant overall survival benefit vs. azacitidine alone, and on the phase Ib M14-358 trial of use in combination with hypomethylating agents.

PharmaTimes