Merck Receives the EMA’s CHMP Positive Opinion of Keytruda (pembrolizumab) as Adjuvant Treatment for Non-Small Cell Lung Cancer
- The EMA’s CHMP adopted a positive opinion recommending approval of Keytruda for the adjuvant treatment of adults with NSCLC who are at high risk of recurrence following complete resection and Pt-based CT. The EC’s final decision is expected in Q4’23
- The opinion was based on results from the P-III trial (KEYNOTE-091) evaluating Keytruda. The trial was conducted in collaboration with EORTC and ETOP which showed a significant improvement in DFS
- Keytruda, an anti-programmed death receptor-1 (PD-1) therapy was approved in Jan 2023 as monotx. for adjuvant treatment following surgical resection and Pt-based CT for adult patients with stage IB (T2a ≥4 centimeters), II, or IIIA NSCLC in the US
Ref: Merck | Image: Merck
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