Bristol Myers Gets Positive CHMP Opinion for Onureg in Acute Myeloid Leukemia
April 23 2021 - 7:48AM
Dow Jones News
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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