Merck announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of KEYTRUDA, Merck’s anti-PD-1 therapy, as a neoadjuvant treatment combined with platinum-containing chemotherapy, followed by KEYTRUDA as a monotherapy adjuvant treatment for resectable non-small cell lung cancer (NSCLC) at high risk of recurrence in adults.

This recommendation is based on the Phase 3 KEYNOTE-671 trial outcomes, which showed a statistically significant improvement in both overall survival and event-free survival for patients treated with neoadjuvant KEYTRUDA and chemotherapy, followed by KEYTRUDA after surgery, compared to placebo plus chemotherapy followed by placebo.

Eligibility for KEYNOTE-671 trial included patients with previously untreated and resectable NSCLC with a high risk of recurrence, irrespective of tumor PD-L1 expression levels. The CHMP’s opinion is now under review by the European Commission for marketing authorization within the EU, with a final decision anticipated in the first half of 2024.

Dr. Marjorie Green, Senior Vice President at Merck Research Laboratories, expressed optimism for the CHMP’s recommendation, which brings them closer to offering support to patients in Europe with earlier stages of NSCLC.

KEYTRUDA was already approved in the U.S. in October 2023 for the treatment of patients with resectable NSCLC in a similar patient setting. Lung cancer remains the leading cause of cancer-related deaths globally, and despite improvements in detection, screening, and new therapies that have led to better survival rates, there is still a significant unmet need for early detection and screening, especially since many lung cancer cases remain undetected until they are advanced.

Source link: http://www.businesswire.com/news/home/20240222912367/en/Merck-Receives-Positive-EU-CHMP-Opinion-for-KEYTRUDA%C2%AE-pembrolizumab-in-Combination-With-Chemotherapy-as-Neoadjuvant-Treatment-Then-Continued-as-Monotherapy-as-Adjuvant-Treatment-for-the-Treatment-of-Resectable-NSCLC-at-High-Risk-of-Recurrence

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Ferry Darma
Ferry Darma is Director of Media Relations at The Clinical Trial Vanguard. Ferry, a computer data scientist, focuses on the latest clinical trial industry news and trends.