FDA Approves Merck’s Keytruda for First-Line Use in NSCLC

By October 28, 2016Blog Posts, Pharma Beat

Just a few weeks after the European Society of Medical Oncology (ESMO) Conference wrapped up in Denmark, the U.S. FDA has approved Keytruda (pembrolizumab) for first-line use. KEYNOTE-024 was presented at ESMO. The trial showed a significant improvement in progression-free survival (median 10.3 months vs. 6.0 months; hazard ratio 0.50) and overall survival (80% vs. 72% of patients were alive at 6 months; hazard ratio 0.60) in patients with untreated non-small cell lung cancer (NSCLC) whose tumours show at least 50% PD-L1 expression, compared to chemotherapy. PD-L1 is a biomarker which helps identify patients most likely to benefit from Keytruda. About 30% of all NSCLC have tumours with high PD-L1 expression and would be eligible for first-line Keytruda.

The FDA issued approval of Keytruda in the first line setting, in patients whose tumours have high PD-L1 expression, almost two full months ahead of its target decision date of December 24, 2016. Keytruda is the first immunotherapy approved for the first-line treatment of NSCLC.