FDA withdraws Krazati's colorectal cancer indication after confirmatory trial miss
Bristol Myers Squibb (NYSE: BMY), the US pharma major, has withdrawn the accelerated approval of Krazati (adagrasib) in combination with Erbitux (cetuximab) for KRAS G12C-mutated colorectal cancer in the USA, after the confirmatory trial failed to show a clinical benefit.
A US Food and Drug Administration's (FDA) letter confirms that Bristol Myers requested the move and waived its right to the expedited withdrawal procedure.
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