Merck, known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has designated lambrolizumab (MK-3475) as a Breakthrough Therapy for the treatment of patients with advanced melanoma. Lambrolizumab is Merck’s investigational antibody therapy targeting Programmed Death receptor (PD-1) that is currently being evaluated for the treatment of patients with advanced melanoma, and other tumor types.
“We are pleased that the FDA has designated lambrolizumab a Breakthrough Therapy for patients with advanced melanoma,” said Gary Gilliland M.D., Ph.D., senior vice president and oncology franchise head, Merck Research Laboratories. “The FDA’s decision to place lambrolizumab in a category that may enable expedited development and review is an important milestone for Merck as we advance ongoing programs in multiple cancer indications.”
The designation of an investigational drug as a Breakthrough Therapy is intended to expedite the development and review of a candidate that is planned for use, alone or in combination, to treat a serious or life-threatening disease or condition when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints. The Food and Drug Administration Safety and Innovation Act (FDASIA) includes a provision that allows sponsors to request that an investigational drug be designated as a Breakthrough Therapy. The implications of Breakthrough Therapy Designation cannot be determined at this time.
In November 2012, early interim results from a single-arm, open-label Phase Ib study of lambrolizumab (MK-3475) administered to 85 patients with advanced (inoperable and metastatic) melanoma were presented at the Society for Melanoma Research of the 9th International Congress of the Society for Melanoma Research (SMR) in Hollywood, Calif.