FDA awards "Breakthrough Therapy" status for Merck & Co's lambrolizumab

US pharma giant Merck & Co (NYSE:MRK) says that the US Food and Drug Administration 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.

Gary Gilliland, senior vice president and oncology franchise head, Merck Research Laboratories, commented: “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.