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FDA Approves Pembrolizumab in Merkel Cell Carcinoma

Gina Columbus @ginacolumbusonc
Published: Wednesday, Dec 19, 2018

The FDA has granted an accelerated approval to pembrolizumab (Keytruda) for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC).1,2

The accelerated approval of pembrolizumab in this setting is contingent on the results of a confirmatory trial. Pembrolizumab has FDA-approved indications in melanoma, lung cancer, head and neck cancer, Hodgkin lymphoma, urothelial carcinoma, gastric cancer, cervical cancer, primary mediastinal large B-cell lymphoma, and microsatellite instability–high solid tumors.


  1. FDA approves pembrolizumab for Merkel cell carcinoma. FDA. Published December 19, 2018." . Accessed December 19, 2018.
  2. 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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