FDA Approves Onureg (azacitidine) for Continued Treatment of Adult AML Patients in First Remission After Intensive Chemotherapy

Not reported in label.

ONUREG is indicated for continued treatment of adult patients with acute myeloid leukemia who achieved first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following intensive induction chemotherapy and are not able to complete intensive curative therapy.

The recommended dosage of ONUREG is 300 mg orally once daily with or without food on Days 1 through 14 of each 28-day cycle. Continue ONUREG until disease progression or unacceptable toxicity. Administer an antiemetic 30 minutes prior to each dose for the first 2 cycles. Do not substitute ONUREG for intravenous or subcutaneous azacitidine. Monitor complete blood count every other week for the first 2 cycles and prior to the start of each cycle thereafter. Dosage modifications are required for adverse reactions such as myelosuppression and gastrointestinal toxicity, including dose interruptions, reductions to 200 mg, and treatment duration reductions.

The efficacy of ONUREG was evaluated in QUAZAR (NCT01757535), a multicenter, randomized, double-blind, placebo-controlled study. Eligible patients were ages 55 years or older, had AML, and were within 4 months of achieving first complete remission (CR) or complete remission with incomplete blood count recovery.

Not reported in label.

Not reported in label.