The FDA has approved pembrolizumab (Keytruda – Merck), a human programmed death receptor-1 (PD-1) blocking antibody, for treatment of unresectable or metastatic melanoma that has progressed following treatment with ipilimumab (Yervoy) and, if the patient is BRAF V600 mutation positive, a BRAF inhibitor. It is the first PD-1 inhibitor to be marketed in the US. Nivolumab, another PD-1 inhibitor, is available in Japan. Pembrolizumab was previously known as lambrolizumab.

STANDARD TREATMENT — Metastatic melanoma has traditionally been treated with the cytotoxic agent dacarbazine (DTIC), which has not been shown to improve survival. Other therapies have included high-dose interleukin-2 (aldesleukin, Proleukin), which has produced responses in 16% of patients, but can cause severe toxicity and requires hospitalization for treatment. The anti-CTLA4 monoclonal antibody ipilimumab has produced response ... more      

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