Policy & Regulation
Bristol Myers Squibb's KRAZATI (adagrasib) combined with cetuximab granted priority FDA review in KRASG12C-mutated colorectal cancer
20 February 2024 -

Biopharmaceutical company Bristol Myers Squibb (NYSE: BMY) announced on Tuesday that the U.S. Food and Drug Administration (FDA) has granted priority review for the supplemental new drug application (sNDA) of KRAZATI (adagrasib) in combination with cetuximab, targeting patients with previously treated KRASG12C-mutated locally advanced or metastatic colorectal cancer (CRC). The FDA set a Prescription Drug User Fee Act (PDUFA) goal date for 21 June 2024.

The submission draws from the results of the KRYSTAL-1 study, a multicohort trial assessing KRAZATI alone or combined with other anticancer therapies in advanced solid tumors with KRASG12C mutation. The study demonstrated promising clinical activity and tolerability for KRAZATI plus cetuximab in patients with CRC harboring a KRASG12C mutation.

KRAZATI (adagrasib) is an oral small-molecule inhibitor of KRASG12C, providing sustained target inhibition, vital for treating cancers with KRASG12C mutations. This mutation occurs in approximately 14% of NSCLC, 3-4% of colorectal cancer, and 1-2% of other cancers.

In 2022, KRAZATI received accelerated approval for treating KRASG12C-mutated NSCLC. The FDA granted breakthrough therapy designation in 2022 for KRAZATI plus cetuximab in KRASG12C-mutated advanced CRC.

KRAZATI's successful developments include conditional marketing authorisation by the European Commission in 2024 for treating KRASG12C-mutated advanced NSCLC. The ongoing evaluation of KRAZATI as monotherapy and in combination with other anti-cancer therapies targets advanced KRASG12C-mutated tumors, spanning NSCLC and colorectal cancer.

Colorectal cancer (CRC) ranks as the third most diagnosed cancer globally, causing significant mortality. Bristol Myers Squibb pioneers cancer research to deliver innovative medicines, aiming to transform patients' lives and provide hope for a cancer-free future.