FDA designates Merck’s investigational advanced melanoma drug as breakthrough therapy

The FDA has designated lambrolizumab as breakthrough therapy for treating advanced melanoma, Merck announced today.

Lambrolizumab (MK-3475), an investigational antibody therapy that targets programmed death receptor (PD1), is being evaluated as treatment for patients with advanced melanoma and other tumor types, Merck said in a press release. Breakthrough therapy is awarded by the FDA to expedite the approval process of drugs used to treat life-threatening or serious diseases that “may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints,” Merck reported.

Early results of a phase 1b study of lambrolizumab for treatment of 85 patients with advanced (inoperable and metastatic) melanoma were presented in November 2012 at the International Congress of the Society for Melanoma Research in Hollywood, Calif. Fifty-one percent of patients showed objective anti-tumor response, including 9% who displayed complete response at or after 12 weeks.

Merck has initiated a global, randomized, phase 2 clinical trial to compare lambrolizumab with standard chemotherapy for patients with advanced melanoma who have not responded to previous therapy.

“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,” Gary Gilliland, MD, PhD, senior vice president and oncology franchise head for Merck Research Laboratories, said.