First targeted therapy for KRAS G12C mutated lung cancer approved in EU

The European Commission (EC) has granted conditional marketing authorization for Lumykras (sotorasib), a first-in-class KRASG12C inhibitor from US biotech giant Amgen (Nasdaq AMGN), for the treatment of adults with advanced non-small cell lung cancer (NSCLC) with KRAS G12C mutation and who have progressed after at least one prior line of systemic therapy. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

"The approval of Lumykras, the first and only targeted therapy for KRAS G12C-mutated NSCLC with proven efficacy, has the potential to transform treatment outcomes for people in the European Union living with this notoriously difficult-to-treat cancer," said Dr David Reese, executive vice president of R&D at Amgen. "Amgen's landmark scientific discovery allowed investigators to advance the first KRASG12C inhibitor into the clinic, and we look forward to bringing this critical innovation to more patients across the globe," he noted.

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