The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of Merck, Sharp & Dohme’s (MSD; NYSE: MRK) anti-PD-1 therapy, Keytruda (pembrolizumab), as an adjuvant treatment for non-small cell lung cancer (NSCLC) in adults who are at a high risk of recurrence. This positive opinion from the CHMP is based on late-stage data that demonstrated a significant improvement in disease-free survival (DFS) among patients receiving the treatment.
Awaiting Final Decision in Q3 2023
A final decision on the approval of Keytruda for this indication is expected in the third quarter of 2023. The recommendation from the CHMP is a crucial step towards potentially expanding the treatment options for patients with high-risk NSCLC in Europe.
Keytruda’s Global Approval Status
Keytruda is already approved as an adjuvant treatment for non-small cell lung cancer in the United States, marking its significance in the global fight against this disease. The therapy’s potential approval in the European Union would further cement its role as a standard of care for patients battling NSCLC.-Fineline Info & Tech
