FDA Approval Summary: Tocilizumab for Treatment of Chimeric Antigen Receptor T Cell‐Induced Severe or Life‐Threatening Cytokine Release Syndrome

• Published in: The oncologist (Dayton, Ohio) Vol. 23; no. 8; pp. 943 - 947
• Main Authors: Le, Robert Q., Li, Liang, Yuan, Weishi, Shord, Stacy S., Nie, Lei, Habtemariam, Bahru A., Przepiorka, Donna, Farrell, Ann T., Pazdur, Richard
• Format: Journal Article
• Language: English
• Published: United States AlphaMed Press 01.08.2018
• Subjects: Chimeric antigen receptor; Cytokine release syndrome; Immunotherapy; Interleukin‐6; Regulatory Issues: FDA; T cell; Tocilizumab; Cytokine release syndrome; Chimeric antigen receptor; Interleukin‐6; Tocilizumab; Immunotherapy; T cell

On August 30, 2017, the U.S. Food and Drug Administration approved Actemra (tocilizumab, Genentech, Inc., South San Francisco, CA) for the treatment of severe or life‐threatening chimeric antigen receptor (CAR) T cell‐induced cytokine release syndrome (CRS) in adults and in pediatric patients 2 year...