By Colin Kellaher
Bristol Myers Squibb on Friday said the European Medicines Agency's Committee for Medicinal Products for Human Use recommended expanded approval of its Augtyro cancer drug in a pair of indications.
The Princeton, N.J., biopharmaceutical company said the recommendation cover Augtyro as a treatment for adults with ROS1-positive advanced non-small cell lung cancer and for certain patients 12 and older with advanced solid tumors expressing a NTRK gene fusion.
The European Commission, which generally follows CHMP's advice, will now review the recommendation, with a decision expected in January.
Bristol Myers said Augtyro, if approved, has the potential to be a best-in-class treatment for patients with advanced ROS1-positive non-small cell lung cancer in the European Union.
The U.S. Food and Drug Administration last year approved Augtyro for adults with ROS1-positive non-small cell lung cancer and earlier this year gave a green light to the drug in patients with NTRK-positive solid tumors.
Bristol Myers reported Augtyro sales of $23 million for the first nine months of 2024.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
November 15, 2024 07:34 ET (12:34 GMT)
Copyright (c) 2024 Dow Jones & Company, Inc.
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