The Food and Drug Administration has approved the PD-1 inhibitor nivolumab for patients with unresectable or metastatic melanoma who no longer respond to other drugs.
Nivolumab, marketed as Opdivo, is intended for patients who have been previously treated with ipilimumab and, for patients whose tumors express a BRAF V600 mutation, for use after treatment with ipilimumab and a BRAF inhibitor, according to the FDA statement .
“Opdivo is the seventh new melanoma drug approved by the FDA since 2011,” Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA Center for Drug Evaluation and Research, said in the statement. “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.”
The FDA granted nivolumab breakthrough therapy designation and it was approved under the agency’s accelerated approval program.
Approval was based on CheckMate-037, a trial that demonstrated a 32% objective response rate with nivolumab vs. 11% with investigator’s choice chemotherapy among 120 patients with unresectable metastatic melanoma that progressed despite prior ipilimumab or a BRAF inhibitor, if BRAF mutation-positive.
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, according to the FDA statement
Opdivo is marketed by Bristol-Myers Squibb.
