EC approves Amgen's Lumykras for patients with KRAS G12C-mutated lung cancer
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Amgen (NASDAQ:AMGN)
announces that the European Commission (EC) has granted conditional marketing authorization for LUMYKRAS (sotorasib), 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.

The EC decision follows the recommendation for approval by the CHMP and is based on the positive results from the Phase 2 CodeBreaK 100 clinical trial in NSCLC. LUMYKRAS 960 mg demonstrated an objective response rate of 37.1% and a median duration of response of 11.1 months.
Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trials.
Last month, Amgen's Otezla was OK'd in U.S. for plaque psoriasis.