Bristol Myers Gets Priority FDA Review of Expanded Krazati Use

By Colin Kellaher

Bristol Myers Squibb won a priority review from the U.S. Food and Drug Administration for its application seeking expanded approval of its cancer drug Krazati in certain patients with colorectal cancer.

The Princeton, N.J., biopharmaceutical company on Tuesday said the application covers Krazati in combination with cetuximab for the treatment of patients with previously treated KRAS(G12C)-mutated locally advanced or metastatic colorectal 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 June 21 for its application.

Krazati is the key asset of Mirati Therapeutics, which Bristol Myers acquired in a deal that closed in January.

Write to Colin Kellaher at [e-mail]

(END) Dow Jones Newswires

02-20-24 0811ET