FDA Approval Summary: Pembrolizumab for the Treatment of Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma with Disease Progression on or After Platinum‐Containing Chemotherapy

• Published in: The oncologist (Dayton, Ohio) Vol. 22; no. 7; pp. 873 - 878
• Main Authors: Larkins, Erin, Blumenthal, Gideon M., Yuan, Weishi, He, Kun, Sridhara, Rajeshwari, Subramaniam, Sriram, Zhao, Hong, Liu, Chao, Yu, Jingyu, Goldberg, Kirsten B., McKee, Amy E., Keegan, Patricia, Pazdur, Richard
• Format: Journal Article
• Language: English
• Published: United States AlphaMed Press 01.07.2017
• Subjects: Adult; Aged; Aged, 80 and over; Antibodies, Monoclonal, Humanized - adverse effects; Antibodies, Monoclonal, Humanized - therapeutic use; Antineoplastic Agents - adverse effects; Antineoplastic Agents - therapeutic use; Carcinoma, Squamous Cell - drug therapy; Carcinoma, Squamous Cell - pathology; Drug Approval; Female; Head and Neck Neoplasms - drug therapy; Head and Neck Neoplasms - pathology; Humans; Immunotherapy; Male; Middle Aged; Pembrolizumab; Platinum Compounds - therapeutic use; Programmed cell death 1 receptor; Regulatory Issues: FDA; Squamous Cell Carcinoma of Head and Neck; Squamous cell carcinoma of the head and neck; Treatment Outcome; U.S. Food and Drug Administration; Squamous cell carcinoma of the head and neck; Programmed cell death 1 receptor; U.S. Food and Drug Administration; Pembrolizumab; Immunotherapy
• ISSN: 1083-7159; 1549-490X; 1549-490X
• DOI: 10.1634/theoncologist.2016-0496

On August 5, 2016, the U.S. Food and Drug Administration granted accelerated approval to pembrolizumab (KEYTRUDA injection, Merck Sharp & Dohme Corp., Kenilworth, NJ) for treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on...