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Merck Receives the EMA’s CHMP Positive Opinion of Keytruda (pembrolizumab) as Adjuvant Treatment for Non-Small Cell Lung Cancer

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Merck Receives the EMA’s CHMP Positive Opinion of Keytruda (pembrolizumab) as Adjuvant Treatment for Non-Small Cell Lung Cancer

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  • 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

Related News:- Merck and Eisai Discontinue P-III Trial (LEAP-010) of Keytruda + Lenvima for Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

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Neha Madan

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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