Europe Approves Amgen's KRAS-Targeted Lung Cancer Therapy

The European Commission (EC) has granted conditional marketing authorization to Amgen Inc's AMGN Lumykras (sotorasib), a KRASG12C inhibitor, for non-small cell lung cancer (NSCLC).

• The approval covers adult NSCLC patients with KRAS G12C mutation and who have progressed after at least one prior line of systemic therapy. 
• In May 2021, Lumakras was the first KRASG12C inhibitor to receive regulatory approval with its approval in the U.S., under accelerated approval.
• Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
• The EC decision follows the recommendation for approval by the Committee for Medicinal Products for Human Use. It is based on the positive results from the Phase 2 CodeBreaK 100 clinical trial. 
• Lumykras demonstrated an objective response rate of 37.1% and a median duration of response (DoR) of 11.1 months. 
• Price Action: AMGN shares closed higher by 0.94% at $227.29 on Friday.