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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.

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Oral AML Treatment That Demonstrated

Over 2 years median overall survival1*

There’s something you don’t see every day

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.
*QUAZAR® AML-0011

The efficacy of ONUREG® was evaluated in QUAZAR® AML-001, a multicenter, randomized, double-blind, placebo controlled, phase III 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 (CRi) with intensive induction chemotherapy. A total of 472 patients who completed induction with or without consolidation therapy were randomized 1:1 to receive ONUREG® 300 mg (n=238) or placebo (n=234) orally on Days 1 to 14 of each 28-day treatment cycle. Efficacy was established on the basis of overall survival (OS). The trial demonstrated a statistically significant improvement in OS for patients randomized to ONUREG® compared with placebo. In the trial, ONUREG® showed a median OS of 24.7 months (95% CI: 18.7, 30.5) vs 14.8 months (95% CI: 11.7, 17.6) for patients receiving placebo (HR 0.69 [95% CI: 0.55, 0.86; P=0.0009]).

AML, acute myeloid leukemia; CI, confidence interval; HR, hazard ratio.

The first and only FDA-approved continued AML treatment for patients in first remission1,2

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