FDA Approval Summary: Pembrolizumab for Recurrent Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Expressing PD‐L1

• Published in: The oncologist (Dayton, Ohio) Vol. 24; no. 1; pp. 103 - 109
• Main Authors: Fashoyin‐Aje, Lola, Donoghue, Martha, Chen, Huanyu, He, Kun, Veeraraghavan, Janaki, Goldberg, Kirsten B, Keegan, Patricia, McKee, Amy E, Pazdur, Richard
• Format: Journal Article
• Language: English
• Published: Hoboken, USA John Wiley & Sons, Inc 01.01.2019
• Subjects: Accelerated approval; Adenocarcinoma - drug therapy; Adenocarcinoma - pathology; Adult; Aged; Aged, 80 and over; Antibodies, Monoclonal, Humanized - pharmacology; Antibodies, Monoclonal, Humanized - therapeutic use; B7-H1 Antigen - metabolism; Esophageal Neoplasms - drug therapy; Esophageal Neoplasms - pathology; Esophagogastric Junction - pathology; Female; GEJ adenocarcinoma; Humans; Male; PD‐L1; Regulatory Issues: FDA; Stomach Neoplasms - drug therapy; Stomach Neoplasms - pathology; United States; United States Food and Drug Administration; Young Adult; United States; Accelerated approval; GEJ adenocarcinoma; PD‐L1

On September 22, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval for pembrolizumab (Keytruda, Merck & Co., Inc., Whitehouse Station, NJ) for the treatment of patients with recurrent, locally advanced or metastatic, gastric or gastroesophageal junction (GEJ) adenoca...