Merck has announced 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 the programmed death receptor (PD-1) that is currently being evaluated for the treatment of patients with advanced melanoma and other tumor types.
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.
Lambrolizumab is an investigational antibody therapy designed to disrupt the action of the immune checkpoint protein PD-1 and therefore inhibit the ability of some cancers to evade the body’s immune system. The agent is being studied in multiple cancer types including melanoma and non-small cell lung cancer.
In November 2012, early interim results from a single-arm, open-label phase Ib study of lambrolizumab 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 in Hollywood, California. ■