Bristol Myers Gets Speedy FDA Review of Expanded Augtyro Use

By Colin Kellaher

Bristol Myers Squibb won a priority review from the Food and Drug Administration for its application seeking expanded approval of its Augtyro cancer drug.

The New York biopharmaceutical company on Tuesday said the application covers Augtyro in patients 12 and older with solid tumors that have a neurotrophic tyrosine receptor kinase gene fusion and are locally advanced or metastatic, or where surgical resection is likely to result in severe morbidity.

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 regulator set a target action date of June 15 for the application.

Augtyro was the key asset in Bristol Myers's $4.1 billion acquisition of Turning Point Therapeutics in 2022. The FDA late last year approved the drug for adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer.

Write to Colin Kellaher at [e-mail]

(END) Dow Jones Newswires

02-14-24 0740ET