Bristol-Myers stock gains on new Krazati label (NYSE:BMY)

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.