FDA's on­col­o­gy ad­comm votes against Am­gen's con­fir­ma­to­ry da­ta for Lumakras in cer­tain types of NSCLC

The FDA and its on­col­o­gy ad­vi­so­ry com­mit­tee raised lots of ques­tions on whether Am­gen’s con­fir­ma­to­ry tri­al is enough to con­vert an ac­cel­er­at­ed ap­proval to a full ap­proval for Lumakras (so­tora­sib) to treat those with KRAS G12C mu­tat­ed lo­cal­ly ad­vanced or metasta­t­ic non-small cell lung can­cer (NSCLC).

And the ad­comm vot­ed 10 to 2 against whether the pri­ma­ry end­point, pro­gres­sion-free sur­vival (PFS) per blind­ed in­de­pen­dent cen­tral re­view (BI­CR), can be re­li­ably in­ter­pret­ed in the con­fir­ma­to­ry tri­al, known as Code­BreaK 200.

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