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FDA Grants Priority Review to PD-1 Inhibitor Pembrolizumab in Advanced Melanoma

Silas Inman @silasinman
Published: Tuesday, May 06, 2014

Dr. Roger M. Perlmutter

Roger M. Perlmutter, MD, PhD

The FDA has assigned a priority review designation to the PD-1 inhibitor pembrolizumab (MK-3475) as a treatment for patients with unresectable or metastatic melanoma following progression on ipilimumab (Yervoy). As part of this program, the agency plans to take action on the drug's application within 6 months instead of the standard 10 months under regular review, placing a decision date in late October 2014.
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Community Practice Connections™: New Directions in Advanced Cutaneous Squamous Cell Carcinoma: Emerging Evidence of ImmunotherapyAug 13, 20191.5
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