This site is intended for U.S. Healthcare Professionals.

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.

This website is best viewed using the horizontal display on your tablet device.

This website is best viewed using the vertical display on your mobile device.

Request a Rep

Remission is not the destination, it’s the starting point.

With ONUREG®, help your patients with AML
live longer1,a

NCCN callout

Remission is not the destination, it’s the starting point.

With ONUREG®, help your patients with AML
live longer1,a

NCCN callout

Remission is not the destination, it’s thestarting point.

With ONUREG®, help your patients with AML live longer1,a

NCCN callout Explore ONUREG Survival Data

ONUREG is indicated for continued treatment of adults with AML in first CR or CRi following intensive induction chemotherapy who are unable to complete intensive curative therapy.1

Clinical Guidelines

Oral azacitidine (ONUREG) is the ONLY NCCN Category 1 preferred National Comprehensive Cancer Network® (NCCN®) maintenance treatment option across all risk categories2,b

Review the Guidelines

ONUREG Clinical Conversations

Listen to experts discuss the pivotal
QUAZAR® AML-001 trial of ONUREG

Explore the Video Library

Prophylactic Antiemetics

Patients should take antiemetics prophylactically with ONUREG

Review Dosing Recommendations

aQUAZAR® AML-0011

The efficacy of ONUREG (azacitidine) was evaluated in QUAZAR AML-001, a multicenter, randomized, double-blind, placebo-controlled, phase III study. Eligible patients were aged 55 years or older, had AML, and were within 4 months of achieving first CR/CRi with intensive chemotherapy. Patients were excluded if they were candidates for HSCT at the time of screening. 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 through 14 of each 28-day treatment cycle. Efficacy was established based on OS. ONUREG demonstrated a statistically significant improvement in median OS compared with placebo: 24.7 months (95% CI: 18.7, 30.5) vs 14.8 months (95% CI: 11.7, 17.6), respectively (HR: 0.69 [95% CI: 0.55, 0.86; P=0.0009]).1

bNCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®)2

Category 1 Preferred recommendation applies to patients in the maintenance setting with favorable, intermediate, or adverse risk non-CBF AML that are aged ≥55 (category 2A for other age groups) and who have received prior intensive chemotherapy and whose disease is now in remission; completed no consolidation, some consolidation or a recommended course of consolidation; and for whom no allogeneic HCT is planned.2

Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Acute Myeloid Leukemia Version 2.2024. © National Comprehensive Cancer Network, Inc. 2024. All rights reserved. Accessed March 26, 2024. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

The definition of continued and maintenance treatment by the FDA and NCCN differ based on the AML treatment period in patients with or without CR.2,3

AML, acute myeloid leukemia; CBF, core binding factor; CI, confidence interval; CR, complete remission; CRi, complete remission with incomplete blood count recovery; FDA, Food and Drug Administration; HCT, hematopoietic cell transplantation; HR, hazard ratio; HSCT, hematopoietic stem cell transplantation; NCCN, National Comprehensive Cancer Network® (NCCN®); OS, overall survival.