Bristol Myers Gets FDA Priority Review of Repotrectinib in Certain Non-Small Cell Lung Cancer
May 30 2023 - 07:49AM
Dow Jones News
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)
Copyright (c) 2023 Dow Jones & Company, Inc.
Bristol Myers Squibb (NYSE:BMY)
Historical Stock Chart
From Sep 2023 to Oct 2023
Bristol Myers Squibb (NYSE:BMY)
Historical Stock Chart
From Oct 2022 to Oct 2023