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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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ONUREG®—A PIONEER
ON THE PATH TO OVER 2 YEARS MEDIAN OVERALL SURVIVAL1*

UNPRECEDENTED DATA FOR AML PATIENTS IN FIRST REMISSION

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.

ONUREG®—A PIONEER
ON THE PATH TO OVER 2 YEARS MEDIAN OVERALL SURVIVAL1*

UNPRECEDENTED DATA FOR AML PATIENTS IN FIRST REMISSION

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.

ONUREG®—A PIONEER ON THE PATH TO OVER 2 YEARS MEDIAN OVERALL SURVIVAL1*

UNPRECEDENTED DATA FOR AML PATIENTS IN FIRST REMISSION

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.

Learn more about NCCN Guidelines

THE FIRST AND ONLY AML CONTINUED TREATMENT YOUR PATIENTS CAN TAKE AT HOME1,3

*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; GI, gastrointestinal; HR, hazard ratio.

NCCN Guidelines® Category 1, Preferred recommendation applies to AML patients age ≥60 in the post-induction setting who received previous intensive therapy and were unable to receive any of all recommended consolidation, regardless of risk status. For other intermediate or adverse risk AML patients, oral azacitidine (ONUREG®) is a 2A recommended treatment in the post-induction setting, regardless of consolidation status.

††This is not intended to replace consolidation chemotherapy. In addition, fit patients with intermediate- and/or adverse-risk cytogenetics may benefit from HCT in first CR, and there are no data to suggest that maintenance therapy with oral azacitidine can replace HCT. The panel also notes that the trial did not include younger patients or those with CBF-AML; it was restricted to patients ≥55 years of age with intermediate or adverse cytogenetics who were not felt to be candidates for HCT. Most patients received at least 1 cycle of consolidation prior to starting oral azacitidine.

Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Acute Myeloid Leukemia V.2.2022. © National Comprehensive Cancer Network, Inc. 2022. All rights reserved. Accessed June 14, 2022. 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.

Explore overall survival with ONUREG® (including patients with an NPM1 mutation)

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Find out how GI adverse reactions may decrease over time

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Meet 2 types of patients you may see in your practice

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*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; GI, gastrointestinal; HR, hazard ratio.

NCCN Guidelines® Category 1, Preferred recommendation applies to AML patients age ≥60 in the post-induction setting who received previous intensive therapy and were unable to receive any of all recommended consolidation, regardless of risk status. For other intermediate or adverse risk AML patients, oral azacitidine (ONUREG®) is a 2A recommended treatment in the post-induction setting, regardless of consolidation status.

††This is not intended to replace consolidation chemotherapy. In addition, fit patients with intermediate- and/or adverse-risk cytogenetics may benefit from HCT in first CR, and there are no data to suggest that maintenance therapy with oral azacitidine can replace HCT. The panel also notes that the trial did not include younger patients or those with CBF-AML; it was restricted to patients ≥55 years of age with intermediate or adverse cytogenetics who were not felt to be candidates for HCT. Most patients received at least 1 cycle of consolidation prior to starting oral azacitidine.

Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Acute Myeloid Leukemia V.2.2022. © National Comprehensive Cancer Network, Inc. 2022. All rights reserved. Accessed June 14, 2022. 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.