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FDA Grants Pembrolizumab Priority Review for Merkel Cell Carcinoma

Jason M. Broderick @jasoncology
Published: Tuesday, Sep 04, 2018

Scot Ebbinghaus, MD

Scot Ebbinghaus, MD

The FDA has granted a priority review to a supplemental biologics license application (sBLA) for pembrolizumab (Keytruda) for the treatment of pediatric and adult patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC), according to Merck (MSD), the manufacturer of the PD-1 inhibitor.

The FDA approved the PD-L1 inhibitor avelumab (Bavencio) in March 2017 for the treatment of adults and pediatric patients 12 years and older with metastatic MCC, including those who have not received prior chemotherapy.
Nghiem P, Bhatia S, Lipson EJ, et al. Durable tumor regression and overall survival (OS) in patients with advanced Merkel cell carcinoma (aMCC) receiving pembrolizumab as first-line therapy. J Clin Oncol. 2018;36 (suppl; abstr 9506).

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Medical Crossfire®: What Does Data Tell Us About How to Optimize Checkpoint Inhibitor Strategies Across Lines of Care for Patients with Melanoma?Nov 30, 20191.5
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