FDA sets October adcomm to discuss full approval for Amgen’s Lumakras to treat second-line lung cancer

The FDA will con­vene its on­col­o­gy ad­vi­so­ry com­mit­tee in Oc­to­ber to dis­cuss Lumakras, Am­gen’s KRAS-in­hibit­ing oral med­ica­tion as a sec­ond-line treat­ment for KRAS G12C-mu­tat­ed non-small cell lung can­cer, the agency said in the Fed­er­al Reg­is­ter Mon­day.

Lumakras works by in­hibit­ing a cell sur­face pro­tein known as KRAS, which is linked to sev­er­al types of can­cer. The FDA first grant­ed the drug ac­cel­er­at­ed ap­proval in 2021 af­ter see­ing promis­ing Phase II da­ta from Am­gen’s Code­BreaK100 study.

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