Bristol Myers Gets FDA Priority Review of Repotrectinib in Certain Non-Small Cell Lung Cancer

By Colin Kellaher

Bristol Myers Squibb on Tuesday said the Food and Drug Administration granted priority review to its application seeking approval of repotrectinib for certain patients with lung cancer.

The New York biopharmaceutical company said the application covers the treatment of patients with ROS1-positive locally advanced or metastatic non-small cell lung cancer.

The FDA grants priority review to medicines that have the potential to provide significant improvements in the treatment of a serious disease, and the designation shortens the review period. Bristol Myers said the agency set a target action date of Nov. 27 for the application.

Bristol Myers said repotrectinib, if approved, would provide a potential best-in-class option for patients who are tyrosine kinase inhibitor naive and a potential first-in-class treatment for patients who have previously been treated with TKI and for whom there are currently no approved targeted therapies available.

Repotrectinib was the key asset in Bristol Myers's $4.1 billion acquisition of Turning Point Therapeutics last year.

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

(END) Dow Jones Newswires

May 30, 2023 07:34 ET (11:34 GMT)

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