Following Nivolumab, Pembrolizumab Receives EU Approval as First-Line for Melanoma

Merck (MSD) has announced that its PD-1 inhibitor pembrolizumab (Keytruda) was approved by the European Commission for the treatment of advanced (unresectable or metastatic) melanoma in adults. The approval followed review of data from 3 studies—KEYNOTE-001, KEYNOTE-002, and KEYNOTE-006—to evaluate the efficacy and safety of the drug in 1500 advanced melanoma patients. The drug can now be administered at a dose of 2 mg/kg once in 3 weeks to patients residing in the 28 EU member states.

The approval comes close on the heels of the EU approval of the other PD-1 inhibitor—nivolumab (Opdivo) developed by Bristol Myer’s Squibb (BMS). A BMS press release last month informed on the approval of nivolumab for the treatment of advanced melanoma in adults following an accelerated assessment by the Committee for Medicinal Products for Human Use.

Nivolumab has been assigned priority review for first line in melanoma by the US FDA, with a projected action date of August 27, 2015. BMS submitted phase 3 results from the CheckMate-066 trial, in which the performance of treatment-naïve, advanced melanoma patients (with wild type Braf) on nivolumab was compared with that of patients on dacarbazine chemotherapy. Treatment with nivolumab improved overall survival (OS) by 58% and progression free survival (PFS) by 57% compared with dacarbazine.