Health Canada Approves Merck’s KEYTRUDA for Resectable NSCLC with Chemotherapy

Merck, known as MSD outside of the United States and Canada, announced that Health Canda has granted approval for KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, as a treatment for adult patients with resectable Stage II, IIIA, or IIIB (T3-4N2) non-small cell lung carcinoma (NSCLC) in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery. This approval is based on results from the Phase 3 KEYNOTE-671 trial, which demonstrated statistically significant results for its dual primary endpoints of event-free survival (EFS) and overall survival (OS) versus neoadjuvant placebo plus chemotherapy followed by adjuvant placebo alone.

“While we have made significant advancements for patients with advanced lung cancer, it remains the leading cause of cancer-related deaths in Canada. This underscores the importance of addressing lung cancer cases in earlier stages, to help improve patient outcomes,” stated “Dr. Jonathan Spicer, thoracic surgeon and scientist at the McGill University Health Centre (MUHC), Scientist in the Cancer Research Program at The Institute, Professor of Surgery at McGill University, and Medical Director of the McGill Thoracic Oncology Network.” “This recent approval adds another therapeutic option for patients with operable non-small cell lung cancer.”

“Today, we’ve made a significant step forward with the approval of the first anti-PD-1 therapy in Canada for the perioperative treatment of resectable non-small cell lung cancer. This approval highlights our commitment to expanding treatment options for lung cancer patients,” expressed André Galarneau, PhD, Executive Director & Vice President, Oncology Business Unit at Merck Canada. “We’re excited to continue this progress and collaborate with community partners to help patient affected by this disease.”