New FDA approval for BMS’ Krazati
US pharma major Bristol Myers Squibb (NYSE: BMY) saw its shares close up 2.2% at $41.93 on news of an additonal indication approval for its Krazati (adagrasib) on Friday.
The US Food and Drug Administration granted accelerated approval for Krazati plus cetuximab for adults with KRAS G12C-mutated locally advanced or metastatic colorectal cancer (CRC), as determined by an FDA-approved test, who have received prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.
This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response (DOR) results. Continued approval for this indication may be contingent upon verification and description of a clinical benefit in a confirmatory trial.
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