SILVER SPRING, Md. -- Patients with unresectable or metastatic melanoma not responding to current drug therapies now have another option, with the FDA's approval Monday of nivolumab (Opdivo).
The drug, which blocks the so-called programmed death-1 (PD-1) pathway, is the seventh new agent to be approved for treating melanoma in the past 4 years, in announcing the decision.
Approval was based on trial data from 120 patients evaluated for efficacy and 370 for safety.
In the efficacy studies, 32% of participants receiving nivolumab achieved objective responses (at least 50% shrinkage in tumor volume). The benefit lasted for more than 6 months in approximately one-third of the participants who experienced tumor shrinkage, the FDA said.
Safety analyses indicated that the most common side effects of the drug were rash, itching, cough, upper respiratory tract infections, and edema. The most serious side effects were severe immune-mediated side effects involving healthy organs, including the lung, colon, liver, kidneys, and endocrine glands, according to the agency.
Nivolumab, to be sold by Bristol-Myers Squibb, was cleared under the FDA's accelerated approval program. Normally such approvals come with requirements for follow-up studies to confirm the clinical benefit, but the agency's announcement did not specify what they would be.