Merck’s Keytruda (pembrolizumab) in Combination with Chemotherapy Receives CHMP’s Positive Opinion for the Treatment of Non-Small Cell Lung Cancer  

Shots:  

• The company received the positive opinion based on the results from the P-III (KEYNOTE-671) clinical trial evaluating neoadjuvant Keytruda + platinum-containing CT followed by adjuvant Keytruda monotx. vs neoadjuvant PBO in patients with resectable NSCLC at high risk of recurrence 

• The study met its dual 1EP by demonstrating a statistically significant & clinically meaningful improvement in OS and EFS. Additionally, based on these results the company expects to receive EC’s decision by H1’24  

• Earlier in Oct 2023, Keytruda in combination with platinum-containing CT received the US FDA’s approval for the treatment of patients with resectable (tumors ≥4 cm or node-positive) NSCLC 

Ref: Merck | Image: Merck| Press Release

Related News:- Merck Reports the US FDA’s sBLA Acceptance of Neoadjuvant Keytruda with Priority Review for Locally Advanced Head and Neck Squamous Cell Carcinoma (LA-HNSCC)

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