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…
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