THOUSAND OAKS (dpa-AFX) - 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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