Merck Gets Positive CHMP Opinion For Approval Of KEYTRUDA To Treat Non-Small Cell Lung Cancer

(RTTNews) - Biopharmaceutical company Merck & Co., Inc. (MRK), known as MSD outside of the U.S. and Canada, announced Friday that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of KEYTRUDA.

KEYTRUDA is Merck's anti-PD-1 therapy for the adjuvant treatment of adults with non-small cell lung cancer (NSCLC), who are at high risk of recurrence following complete resection and platinum-based chemotherapy.

The recommendation is based on results from the Phase 3 KEYNOTE-091 trial, in which KEYTRUDA demonstrated a statistically significant improvement in disease-free survival (DFS) in patients with NSCLC who are at high risk of recurrence, and clinically meaningful results in the patients who received adjuvant chemotherapy.

The CHMP's recommendation will now be reviewed by the European Commission for marketing authorization in the European Union, and a final decision is expected in the fourth quarter of 2023.

The KEYNOTE-091 trial, also known as EORTC-1416-LCG/ETOP-8-15 - PEARLS, was conducted in collaboration with the European Organisation for Research and Treatment of Cancer (EORTC) and the European Thoracic Oncology Platform (ETOP).