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CC-486 receives positive CHMP opinion for the treatment of adult patients with AML in first remission

Apr 26, 2021
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Very recently, it was announced that the Committee for Medicinal Products for Human Use (CHMP) recommends the use of CC-486, oral azacitidine, as a maintenance therapy in adults with acute myeloid leukemia (AML) who are in complete remission or complete remission with incomplete hematologic recovery after induction therapy with or without consolidation treatment and who are ineligible or do not choose to undergo hematopoietic stem transplantation.1

The positive opinion is based on results from the phase III QUAZAR AML-001 trial investigating CC‑486 maintenance versus placebo in patients aged ≥55 years and with AML in first remission. The median overall survival in patients who received CC-486 was 24.7 months compared with 14.8 months for those who received placebo (p = 0.0009). Median relapse-free survival was 10.2 months and 4.8 months in the CC‑486 and placebo arms, respectively (p < 0.001).

In September 2020, the results of this trial led to the U.S. Food and Drug Administration (FDA) approval of CC-486 for the maintenance of adult patients with AML in first remission (including complete remission with incomplete hematologic recovery) after intensive induction chemotherapy, who are not able to complete intensive curative therapy. CC-486 was also approved by Health Canada for the same indication in January 2021.2

If approved by the European Medicines Agency (EMA), CC-486 will be the first and only oral, once‑daily, frontline maintenance therapy approved in Europe that has shown a significantly improved overall survival in this patient population. The final decision is expected in 2 months following the positive CHMP opinion.1

  1. PipelineReview.com. Bristol Myers Squibb receives positive CHMP opinion for Onureg® (azacitidine tablets; CC-486) as frontline oral maintenance therapy for adults with acute myeloid leukemia in first remission. https://pipelinereview.com/index.php/2021042477997/Small-Molecules/Bristol-Myers-Squibb-Receives-Positive-CHMP-Opinion-for-Onureg-azacitidine-tablets-CC-486-as-Frontline-Oral-Maintenance-Therapy-for-Adults-with-Acute-Myeloid-Leukemia-in.html. Published Apr 24, 2021. Accessed Apr 26, 2021.
  2. BioSpace. Health Canada approves Onureg® (azacitidine tablets), first maintenance therapy for patients in remission from acute myeloid. https://www.biospace.com/article/releases/health-canada-approves-onureg-and-174-azacitidine-tablets-first-maintenance-therapy-for-patients-in-remission-from-acute-myeloid-leukemia. Published Jan 12, 2021. Accessed Apr 26, 2021.

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