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Amgen's Lumykras Gets Conditional Approval In The EU For NSCLC With KRAS G12C Mutation

Amgen Inc. (AMGN), said on Monday that the European Commission has granted conditional marketing authorization for Lumykras for patients with KRAS G12C-mutated advanced non-small cell lung cancer.

"Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s)," the company said in a statement.

In the U.S., Lumykras was granted accelerated approval by the FDA last May. The drug is now approved in 35 countries around the world.

Lumykras 960 mg, administered orally once-daily, is the first and only targeted therapy for KRAS G12C-mutated non-small cell lung cancer with proven efficacy, Amgen noted.

Non-small cell lung cancer (NSCLC) accounts for approximately 84 percent of the 2.2 million new lung cancer diagnoses globally each year, including approximately 0.4 million new cases in Europe.

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