Merck's Lambrolizumab Receives Breakthrough Therapy Designation

Merck announced that the FDA has designated lambrolizumab (MK-3475) as Breakthrough Therapy for the treatment of patients with advanced melanoma. Lambrolizumab is an investigational antibody therapy targeting Programmed Death receptor (PD-1) which is currently being evaluated for the treatment of patients with advanced melanoma, and other tumor types.

Early interim results from a single-arm, open-label Phase 1b study of lambrolizumab administered to 85 patients with advanced (inoperable and metastatic) melanoma were previously announced.

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. Lambrolizumab is being studied in multiple cancer types including melanoma and non-small cell lung cancer.

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