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Reduced BCG Production Could Put Bladder Cancer Patients at Risk

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.

References:

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.