Bacillus Calmette-Guérin (BCG) is an effective biologic therapy widely used in patients with non-muscle invasive bladder cancer. Sanofi recently announced their intent to discontinue BCG production, leaving Merck as the sole BCG supplier to U.S. patients. Urologists are concerned that a potential BCG shortage could increase the cost of treatment and also lead to rationing of the biologic, thus putting patients at risk.
Sanofi Pasteur statement on discontinuation of BCG. Sanofi Pasteur US website. https://goo.gl/17gsSp. Published November 21 2016.
Katz A. Safofi’s Halt of BCG Production Worries Bladder Cancer Patients and Urologists. OncLive website. http://www.onclive.com/web-exclusives/sanofis-halt-of-bcg-production-worries-bladder-cancer-patients-and-urologists. Published December 01 2016.
April 2012 inspectional observations (form 483). US Food and Drug Administration website. https://goo.gl/3mueUD. Updated January 29, 2015.
Rentsch, CA, Birkhäuser FD, Biot C, et al. Bacillus Calmette-Guérin strain differences have an impact on clinical outcome in bladder cancer immunotherapy. Eur Urol. 2014;66(4):677-88.