BioCentury
ARTICLE | Regulation

Approval of Mirati’s Krazati offers differentiation in KRAS landscape

But will a differentiated safety and efficacy profile translate to market success?

December 13, 2022 2:16 AM UTC

With the approval of Krazati, patients with NSCLC harboring KRAS G12C mutations gain a second targeted treatment option, and Mirati gains its first drug approval more than 25 years into its story. 

FDA granted accelerated approval to Krazati adagrasib as second-line therapy for adults with KRAS G12C-mutated, locally advanced or metastatic non-small cell lung cancer (NSCLC) on Tuesday. Though it’s the second KRAS G12C inhibitor to reach the market for the indication, the company believes it has a differentiated safety and efficacy profile that will influence prescribing decisions. ...

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