CHMP Recommends Bristol-Myers Squibb’s Melanoma Drug Opdivo

Bristol-Myers Squibb’s Opdivo (nivolumab) received a positive opinion from the EMA’s Committee for Medicinal Products for Human Use to treat adult patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection.

Opdivo is a programmed-death 1 (PD-1) immune checkpoint inhibitor designed to harness the body’s own immune system to help restore anti-tumor immune response. It is currently FDA approved to treat 13 different forms of cancer.

CHMP gave a positive opinion for the infusion’s dosing schedule of 240 milligrams infused for 30 minutes every two weeks or 480 mg infused for 60 minutes every four weeks.