The FDA granted accelerated approval to Opdivo (nivolumab), a new treatment for patients with unresectable or metastatic melanoma who no longer respond to other drugs.
Melanoma is a type of cancer forming in the body’s melanocyte cells, which develop the skin’s pigment. Opdivo works by inhibiting the PD-1 protein on cells, which blocks the body’s immune system from attacking the melanoma tumors. Opdivo is intended for patients previously treated with ipilimumab and, for melanoma patients whose tumors express a gene mutation called BRAF v600, for use after treatment with ipilimumab and a BRAF inhibitor.
Opdivo is the 7th new melanoma drug approved by the FDA since 2011. Others include ipilimumab (2011), peginterferon alfa-2b (2011), vemurafenib (2011), dabrafenib (2013), trametinib (2013) and pembrolizumab (2014).
Opvido is being approved under the FDA’s accelerated approval program, which allows approval of a drug to treat a serious or life-threatening disease based on clinical data showing the drug has an effect on a surrogate endpoint reasonably likely to predict clinical benefit to patients. This program provides earlier patient access to promising new drugs while the company conducts additional clinical trials to confirm the drug’s benefit.
Opdivo’s efficacy was demonstrated in 120 clinical trial participants with unresectable or metastatic melanoma. Results showed that 32 percent of participants receiving Opdivo had their tumors shrink (objective response rate). This effect lasted for more than six months in approximately one-third of the participants who experienced tumor shrinkage.
Opdivo’s safety was evaluated in the overall trial population of 268 participants treated with Opdivo and 102 participants treated with chemotherapy. The most common side effects of the drug were rash, itching, cough, upper respiratory tract infections, and fluid retention (edema). The most serious side effects are severe immune-mediated side effects involving healthy organs, including the lung, colon, liver, kidneys and hormone-producing glands.
Opdivo is marketed by Princeton, New Jersey-based Bristol-Myers Squibb.