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Oral AML Treatment That Demonstrated

Over 2 years median overall survival1*

There’s something you don’t see every day

NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) recommend ORAL AZACITIDINE (ONUREG®) in the post-remission setting for patients with AML in first remission who choose not to or are not fit/eligible for allogeneic HCT2‡
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 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.

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

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