FDA Grants Melanoma Drug Accelerated Approval

Nivolumab treats patients with unresectable or metastatic melanoma who no longer respond to other drugs.

The FDA today granted accelerated approval for a drug that treats patients with unresectable or metastatic melanoma who no longer respond to other drugs.

Nivolumab (Opdivo) inhibits the PD-1 protein on cells, thereby preventing the protein from blocking the body’s immune system from attacking melanoma tumors. Nivolumab is intended for patients previously treated with ipilimumab and those whose tumors express the BRAF V600.

“Opdivo is the seventh new melanoma drug approved by the FDA since 2011,” said Richard Pazdur, MD, director of the FDA Office of Hematology and Oncology Products, in a press 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.”

Opdivo was approved more than 3 months ahead of the prescription drug user fee goal date of March 30, 2015, which is when the FDA was scheduled to complete its review of the application.

In a clinical trial, nivolumab was evaluated in 120 patients with unresectable or metastatic melanoma. The researchers found that 32% of participants receiving nivolumab saw their tumors shrink. The shrinkage lasted for more than 6 months in approximately one-third of participants whose tumors were reduced.

In the overall trial population of 268 patients treated with nivolumab and 102 patients treated with chemotherapy, the most common side effects were rash, itching, cough, upper respiratory tract infections, and edema.

Serious adverse events experienced on nivolumab involved severe immune-mediated side effects in healthy organs, including the lung, colon, liver, kidneys, and hormone-producing glands.