Merck & Co. announced on Friday that the European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the expanded approval of Keytruda, a blockbuster cancer drug, for certain patients with non-small cell lung cancer.
Expanded Approval Recommendation
The recommendation specifically covers Keytruda in combination with platinum-containing chemotherapy as neoadjuvant treatment, followed by continued monotherapy as adjuvant treatment. This approval is targeted at adults with resectable non-small cell lung cancer who are at high risk of recurrence.
Decision Pending
Merck anticipates that the European Commission, typically in alignment with the CHMP’s guidance, will make a decision in the first half of the year regarding this expanded approval.
Keytruda: A Leading Cancer Drug
With lung cancer being the top cause of cancer-related deaths globally, the focus on non-small cell lung cancer, which accounts for 80% of all lung cancer cases, is crucial. Keytruda, known for utilizing the patient’s immune system to combat tumors, is under extensive study in various trials targeting different cancers and treatment scenarios. The drug, already approved for numerous indications worldwide, achieved sales exceeding $25 billion last year.
