EU approves Keytruda (pembrolizumab) for metastatic non-small cell lung cancer in adults whose tumors have high PD-L1 expression with no EGFR or ALK positive tumor mutations- Merck Inc

Merck Inc announced that the European Commission has approved Keytruda (pembrolizumab), the company’s anti-PD-1 therapy, for the first-line treatment of metastatic non-small cell lung cancer (NSCLC) in adults whose tumors have high PD-L1 expression (tumor proportion score [TPS] of 50 percent or more) with no EGFR or ALK positive tumor mutations.

The approval is based on phase III data which demonstrated superior overall survival (OS) and progression-free survival (PFS) with Keytruda compared to chemotherapy, the current standard of care for advanced NSCLC. The approval allows marketing of Keytruda in all 28 EU member states plus Iceland, Lichtenstein and Norway, at the approved dose of 200 mg every three weeks until disease progression or unacceptable toxicity.

Comment: In August 2016, Keytruda (pembrolizumab) (2 mg/kg every three weeks) was approved in Europe for previously-treated patients with locally advanced or metastatic NSCLC whose tumors express PD-L1 (TPS of 1 percent or more) and who have received at least one prior chemotherapy regimen.