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Amgen's Lumykras Garners European Commission Conditional Approval for KRAS-Mutated Lung Cancer

NEW YORK – Amgen on Monday announced that the European Commission has granted conditional marketing authorization to sotorasib (Lumykras in the EU; Lumakras in the US) for KRAS G12C-mutated advanced non-small cell lung cancer patients who have progressed on systemic therapy.

The action marks the first regulatory approval of a targeted therapy for KRAS G12C-mutated cancer patients in the European Union. The European Commission approved sotorasib based on data from the CodeBreaK-100 trial, in which the objective response rate was 37 percent, and the median duration of response was 11.1 months.

The US Food and Drug Administration also relied on the CodeBreaK-100 trial data to grant accelerated approval to sotorasib in 2021 for the same indication, and as such, Amgen may need to provide data from confirmatory trials to achieve full approval of its drug. Similarly, in November, the European Medicines Agency's Committee for Medicinal Products for Human Use recommended conditional approval for sotorasib for previously treated, advanced KRAS G12C-mutated NSCLC patients. The EC followed CHMP's recommendation, and therefore, continued approval of sotorasib may be contingent on verification of clinical benefit in confirmatory trials.

There are approximately 400,000 new NSCLC diagnoses in Europe annually, and between 13 percent and 15 percent of patients with non-squamous NSCLC harbor a KRAS G12C mutation in their tumors. The EC's approval paves the way for sotorasib to become available for this subset of NSCLC patients in all European Union member countries as well as Norway, Iceland, and Liechtenstein. Next, local reimbursement authorities will determine whether they will support access to the drug.