hapabapa The U.S. Food and Drug Administration (FDA) on Friday greenlighted Bristol-Myers Squibb's ( NYSE: BMY ) marketing application to expand the label for its lung cancer therapy Krazati to include patients with colorectal cancer.
Accordingly, Krazati, added to Bristol-Myers' ( BMY ) portfolio with its $4.8B Mirati acquisition this year, will be indicated in the U.S.
as a late-line combination therapy for adults with colorectal cancer. The treatment is approved for use in combination with the anticancer agent cetuximab for KRAS G12C -mutated locally advanced or metastatic CRC as determined by an FDA-approved test. The oral KRAS G12C inhibitor, also known as adagrasib, was first approved in 2022 as a single agent and a late-line option for adults with KRAS G12C -mutated non-small cell lung cancer.
The FDA accepted Bristol-Myers's ( BMY ) supplemental new drug application ((sNDA)) to expand its label in February, granting June 21 as its target action date. Both indications were cleared under the FDA's accelerated path for drug approvals, which requires developers to prove the drug's clinical benefit in confirmatory studies. More on Bristol-Myers Squibb Bristol-Myers Squibb: Move Investing Time Horizon To 2025, At Least Bristol-Myers Squibb: Could This Be A Value Trap? (Technical Analysis) Bristol-Myers Squibb Company (BMY) Goldman Sachs 45th Annual Global Healthcare Conference Bristol Myers Opdivo injectable accepted for EU review EU to require additional cancer risk labeli.
