FDA Approves BMS’ Melanoma Drug Opdivo

The FDA has approved Bristol-Myers Squibb’s melanoma treatment Opdivo through its breakthrough therapy pathway, the latest effort by the agency over the past three years to spur development of skin cancer drugs.

Opdivo (nivolumab) is intended to treat patients with melanoma that cannot be removed through surgery and patients with advanced melanoma that isn’t responding to other drugs. The product inhibits the programmed death receptor protein (PD-1) on cells, which blocks the body’s immune system from attacking melanoma tumors, the FDA said.

Approval was supported in part by a study of 120 patients that showed 32 percent of the subjects who received Opdivo had their tumors shrink, the FDA said.

The drug joins Merck’s Keytruda (pembrolizumab) as one of only two PD-1 inhibitors on the market, said Tim Turnham, executive director of the Melanoma Research Foundation. Other melanoma treatments approved during the past three years include BMS’ Yervoy (ipilimumab) and Genentech’s Pegasys (peginterferon alfa-2b). — Robert King