EMA backs sotorasib for KRAS-mutated advanced NSCLC

medwireNews: The EMA’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval of sotorasib for the treatment of patients with advanced non-small-cell lung cancer (NSCLC) harboring a KRAS G12C mutation.

Suitable patients must have progressed after one or more prior lines of systemic therapy.

This recommendation follows the CodeBreaK 100 trial, which demonstrated improved objective response rates and response durations in this patient population, and US approval of the drug for this indication.

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