By Colin Kellaher

 

Bristol Myers Squibb Co. on Friday said the European Medicines Agency's Committee for Medicinal Products for Human Use recommended approval of Onureg as a maintenance therapy in certain patients with acute myeloid leukemia.

The New York biopharmaceutical company said the recommendation covers adults who achieved complete remission or complete remission with incomplete blood count recovery following induction therapy with or without consolidation treatment and who aren't candidates for hematopoietic stem-cell transplantation.

Bristol Myers said Onureg, if approved, would be the first and only once-daily oral frontline maintenance therapy in Europe to show significant overall survival in patients with a broad range of acute myeloid leukemia subtypes in first remission.

The European Commission, which generally follows CHMP's advice, will review the recommendation and is expected to make a final decision within 67 days of receipt, the company said.

 

Write to Colin Kellaher at colin.kellaher@wsj.com

 

(END) Dow Jones Newswires

April 23, 2021 07:33 ET (11:33 GMT)

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