The FDA granted regular approval to Bristol-Myers Squibb’s Opdivo (nivolumab), an anti-PD1 monoclonal antibody.
The approval covers the adjuvant treatment of melanoma patients with involvement of lymph nodes or in metastatic disease patients with complete resection. This builds on its previous approval for metastatic or unresectable melanoma.
The approval was based on a 906-patient trial that found improvement in recurrence-free survival. The agency recommends the drug in 240 mg doses as an IV infusion every two weeks for a maximum of one year.