ROCHESTER, Minn. — Mayo Clinic Cancer Center announced today that it is participating in an expanded access program for the experimental cancer drug MK-3475 at its three sites in Arizona, Florida and Minnesota. MK-3475 is a therapy for the treatment of metastatic melanoma. This program will provide expanded access to the drug prior to its approval by the Food and Drug Administration (FDA).
MK-3475 received “breakthrough therapy” designation from the FDA based on early interim results from a single-arm, open-label Phase I study in 85 patients with surgically unresectable metastatic melanoma. In that trial, the drug had a 51 percent objective response rate. The objective response includes patients with a complete response, those whose tumors were no longer detectable, and those whose tumors shrunk by at least 30 percent compared to baseline.