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# Expanded Access to TICE BCG Substitute
- URL: https://www.fdaweb.com/expanded-access-to-tice-bcg-substitute/
- Published: 2025-02-19T12:00:00.000Z
- Updated: 2026-09-14T14:53:31.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158685

FDA has approved an expanded access program authorizing ImmunityBio to provide recombinant BCG to urologists to address the TICE BCG shortage to treat bladder cancer. A company [statement](https://www.businesswire.com/news/home/20250219106197/en/FDA-Authorizes-ImmunityBio-to-Provide-Recombinant-BCG-rBCG-to-Urologists-to-Address-TICE%C2%AE-BCG-Shortage?ref=fdaweb.com) says the alternative BCG source was developed by the Serum Institute of India.

Recombinant BCG (Bacillus Calmette-Guérin) is described as a benign bacterium originally developed as a live vaccine against tuberculosis.