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FDA Approves Nivolumab for Melanoma

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The United States Food and Drug Administration (FDA) has approved the agent Opdivo (nivolumab) for the treatment of advanced melanoma.

Melanoma is a type of skin cancer that often begins in the form of a mole. Curative type surgery typically requires surgical removal of the cancer; however, if melanoma is deemed unable to be surgically removed, either due to its extensive nature of spread throughout the body, or the fact that it has grown in an area that proves too risky to be surgically removed, it is referred to as unresectable.

Metastatic melanoma refers to melanoma that has spread from its site of origin to distant sites in the body.

Nivolumab is an agent that blocks the body’s own PD-1 proteins on cells. Typically, PD-1 proteins block the body’s immune system from attacking the melanoma cells. Therefore, through blocking PD-1 proteins, the immune system is enabled to fight melanoma cells through that particular pathway.

The trial prompting approval of nivolumab included 120 participants with unresectable or metastatic melanoma.

Nearly one-third of patients experienced a regression in their cancer.
Approximately one-third of these responders had an anti-cancer effect that lasted more than 6 months.
Nivolumab is indicated for patients with unresectable or metastatic melanoma that has stopped responding to prior therapies. Patients must have received prior treatment with ipilimumab and a BRAF inhibitor. Melanoma must express the BRAF V600 mutation.

Reference: United States Food and Drug Administration (FDA). FDA approves Opdivo for advanced melanoma. Available at: http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm427716.htm. Accessed December 23 2014.