Posted by Michael Wonder on 01 Sep 2020
FDA approves Onureg (azacitidine tablets) for acute myeloid leukaemia
1 September 2020 - Today, the FDA approved azacitidine tablets (Onureg, Celgene) for continued treatment of patients with acute myeloid leukaemia who achieved first complete remission or complete remission with incomplete blood count recovery following intensive induction chemotherapy and are not able to complete intensive curative therapy.
Efficacy was investigated in QUAZAR, a multi-centre, randomised, double-blind, placebo-controlled trial. Patients (n=472) who achieved complete remission or complete remission with incomplete blood count recovery with intensive induction chemotherapy with or without receiving subsequent consolidation therapy were randomised 1:1 to receive Onureg 300 mg (n=238) or placebo (n=234) orally on days 1 to 14 of each 28 day cycle.
The main efficacy outcome measure was overall survival.
