Drug major Merck & Co., Inc. (MRK) announced Friday that the European Medicines Agency's Committee for Medicinal Products for Human Use or CHMP adopted a positive opinion recommending approval of its anti-PD-1 therapy KEYTRUDA, in combination with platinum-containing chemotherapy.
The recommendation is for the combination as neoadjuvant treatment, then continued as a monotherapy as adjuvant treatment, for the treatment of resectable non-small cell lung cancer or NSCLC at high risk of recurrence in adults.
The CHMP's recommendation will now be reviewed by the European Commission for marketing authorization in the European Union. A final decision is expected in the first half of 2024.
The positive opinion was based on positive overall survival and event-free survival results from the Phase 3 KEYNOTE-671 trial. In this, neoadjuvant KEYTRUDA plus chemotherapy followed by adjuvant KEYTRUDA as a single agent after surgical resection demonstrated statistically significant and clinically meaningful improvements in the study's dual primary endpoints, versus neoadjuvant placebo plus chemotherapy followed by adjuvant placebo in these patients.
Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories, said, "The CHMP's positive opinion puts us another step closer to helping certain patients in Europe with earlier stages of non-small cell lung cancer, regardless of PD-L1 expression. We look forward to the European Commission's decision, as we continue to build on the legacy of KEYTRUDA in certain types of lung cancer and pursue meaningful advances that may help extend the lives of patients."
In October 2023, KEYTRUDA was approved in the U.S. for the treatment of patients with resectable NSCLC in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery.
Earlier this week, the U.S. Food and Drug Administration accepted for priority review a new supplemental Biologics License Application or sBLA seeking approval for KEYTRUDA (pembrolizumab) in combination with standard of care chemotherapy (carboplatin and paclitaxel). This will be followed by KEYTRUDA as a single agent for the treatment of patients or primary advanced or recurrent Endometrial Carcinoma.
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