BMS’ PD-1 Inhibitor Opdivo Wins EU Approval

The European Commission has approved Bristol-Myers Squibb’s Opdivo as both a first-line and second-line treatment for adults with advanced melanoma, allowing the drug to be marketed in all 28 member states.

The action follows an accelerated assessment by the European Medicines Agency’s Committee for Medicinal Products for Human Use in April. Opdivo (nivolumab) is a PD-1 inhibitor, a class of drugs that works by blocking a protein that keeps the immune system from recognizing and attacking cancer cells.

The Commission based its approval on two Phase 3 trials that demonstrated superior overall survival and response rate for treatment-naïve patients with advanced melanoma. In April, BMS cut short the comparative arm of a trial of Opdivo after interim results showed a clear benefit over chemotherapy.

This latest approval adds to a growing list for Opdivo, starting with Japan in July 2014. The drug won U.S. approval last December as a breakthrough therapy for melanoma, followed in March by approval as a second-line treatment for metastatic squamous non-small cell lung cancer. — John Bechtel