FDA Approves New Skin Cancer Rx

Bristol Myers Squibb melanoma drug Opdivo gets accelerated approval

(RxWiki News) Bristol-Myers Squibb's new skin cancer drug has been approved by the US Food and Drug Administration (FDA).

The FDA granted accelerated approval to Opdivo to treat patients with advanced melanoma that cannot be removed by surgery and who no longer respond to other drugs.

Opdivo inhibits the PD-1 protein on cells. This protein blocks the immune system from attacking melanoma tumors.

According to the FDA, Opdivo is intended for melanoma patients who have previously been treated with ipilimumab and for melanoma patients whose tumors have a gene mutation called BRAF V600 after treatment with ipilimumab and a BRAF inhibitor.

"Opdivo is the seventh new melanoma drug approved by the FDA since 2011,” said Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.

"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," said Dr. Pazdur in an FDA press release.

This approval comes ahead of the scheduled review date, according to Reuters. The FDA had planned its review date for March 30.

Review Date: 
December 22, 2014