Merck announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has given a positive opinion recommending the approval of Keytruda + platinum-based chemotherapy as neoadjuvant therapy, followed by Keytruda as adjuvant therapy in patients with resectable non-small cell lung cancer (NSCLC) at high risk of recurrence.

The recommendation is based on the results of a phase III trial showing that Keytruda + chemotherapy followed by adjuvant Keytruda after surgical resection demonstrated clinically and statistically significant improvements in overall survival and event-free survival, compared with placebo + chemotherapy followed by adjuvant placebo in these patients.

The CHMP recommendation will now be considered by the European Commission for marketing authorization in the European Union (EU), with a final decision expected in the first half of 2024.

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