The US Food and Drug Administration (FDA) granted accelerated approval to Opdivo (nivolumab) for patients with unresectable metastatic melanoma who no longer respond to other drugs.
Opdivo inhibits the PD-1 protein on cells, which blocks the body’s immune system from attacking melanoma tumors. The new treatment is for patients who have been 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.
Results showed that 32% of participants receiving Opdivo had their tumors shrink, and this effect lasted for more than 6 months in approximately one-third of the participants who experienced tumor shrinkage.
The new PD-1 blocker is marketed by Bristol-Myers Squibb.
“Opdivo is the seventh new melanoma drug approved by the FDA since 2011,” says Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, in a news release. “The continued development and approval of novel therapies based on our increasing understanding of tumor immunology and molecular pathways are changing the treatment paradigm for serious and life-threatening diseases.”
Other FDA-approved treatments for melanoma include ipilimumab (2011), peginterferon alfa-2b (2011), vemurafenib (2011), dabrafenib (2013), trametinib (2013), and pembrolizumab (2014). Pembrolizumab is also a PD-1 blocker for melanoma. Opdivo is being approved more than 3 months ahead of the prescription drug user fee goal date of March 30, 2015, the date when the agency was scheduled to complete its review of the application.
The FDA granted Opvido breakthrough therapy designation, priority review, and orphan product designation because the sponsor demonstrated through preliminary clinical evidence that it may offer a substantial improvement over available therapies; the drug had the potential, at the time of the application was submitted, to be a significant improvement in safety or effectiveness in the treatment of a serious condition; and the drug is intended to treat a rare disease, respectively.
Opdivo’s efficacy was demonstrated in a trial of 120 patients with unresectable or metastatic melanoma. Results showed that 32% of participants receiving Opdivo had their tumors shrink, and this effect lasted for more than 6 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 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.