First Anti-PD-1 Drug Approved by FDA for Patients with Advanced Melanoma

Friday, September 5, 2014

On September 4, 2014, the FDA approved the use of pembrolizumab, an immunotherapy drug that blocks the protein PD-1, for patients with advanced melanoma. Pembrolizumab is the first anti-PD-1 therapy to be approved by the FDA.

MSK physicians played a major role in the Phase I clinical trials that led to pembrolizumab’s approval (the drug was granted breakthrough designation, allowing it to reach the market without the need for a typical Phase III study) and are continuing to conduct trials using the therapy in melanoma and other cancers.

Melanoma and Immunotherapeutics Service Chief Jedd Wolchok is available to discuss how pembrolizumab works and what’s on the horizon for this new class of immunotherapy treatments. To set up an interview, contact the Media Staff.

Additional Background

Memorial Sloan Kettering’s Jedd Wolchok Describes Stunning Success of Cancer Immunotherapy

Cancer Immunotherapy Named Science Magazine “Breakthrough of the Year”