Merck today announced that the , (EC) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with platinum-containing chemotherapy as neoadjuvant treatment, then continued as monotherapy as adjuvant treatment, for resectable non-small cell lung cancer (NSCLC) at high risk of recurrence in adults.

This approval by the EC follows the positive recommendation from the Committee for Medicinal Products for Human Use received in February 2024 and was based on results from the Phase 3 KEYNOTE-671 trial.

“Despite the clinical advances for patients with metastatic lung cancer, lung cancer continues to be the leading cause of cancer death in Europe, reinforcing the need to treat these patients in earlier stages of their disease, where we may have the most impact,” said Dr. Solange Peters, chair of the medical oncology and thoracic malignancies department, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland.

“The approval of this KEYTRUDA-based regimen is an important milestone for patients diagnosed with resectable non-small cell lung cancer at high risk of recurrence, regardless of PD-L1 expression, providing a new option for these patients that has shown, through the results of the Phase 3 KEYNOTE-671 trial, the potential to help extend their lives.”

This approval allows marketing of this KEYTRUDA regimen for this indication in all 27 EU member states, as well as Iceland, Liechtenstein, Norway and Northern Ireland.

“Today’s approval of the first anti-PD-1/L1 therapy as part of a treatment regimen in Europe for the neoadjuvant followed by adjuvant treatment of resectable NSCLC based on positive overall survival results demonstrates our continued progress to advance treatments in earlier stages of lung cancer,” said Marjorie Green, Senior Vice President and Head of Oncology, Global Clinical Development, Merck Research Laboratories. “We are eager to build on this momentum as we plan to seek additional approvals of this regimen around the world, and to work together with the cancer community to help drive earlier diagnoses of lung cancer, an urgent need.”