Sunday 9th of January 2022 11:19:46 PM

EC approves Amgen's Lumykras for patients with KRAS G12C-mutated lung cancer

Lung cancer. lung disease. 3d illustration Mohammed Haneefa Nizamudeen/iStock via Getty Images
  • 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.


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