Amgen Gets Nod From Euro Panel for Non-Small Cell Lung Cancer Med

 First Targeted Therapy for the KRAS G12C Mutation Recommended for Approval in the European Union

Positive Opinion Based on Clinical Results Demonstrating Durable Responses and a Favorable Benefit-Risk Profile With LUMYKRAS

KRAS G12C Mutation Shown to be Present in Approximately 13-15% of Patients in Europe With NSCLC[1],[2]

Amgen (NASDAQ: AMGN) today announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending conditional marketing authorization of LUMYKRAS® (sotorasib), known as LUMAKRAS® in the U.S., 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. If the European Commission follows the recommendation for approval, LUMYKRAS will be the first targeted therapy available in the European Union (EU) for the KRAS G12C mutation, one of the most prevalent biomarkers in NSCLC.

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