FDA Approves ImmunityBio's BCG Alternative for Bladder Cancer Treatment

The FDA has authorized ImmunityBio's BCG alternative for bladder cancer treatment, responding to Tice BCG supply shortages. The alternative BCG (rBCG) source has shown promising outcomes in European clinical trials, demonstrating immunogenicity and enhanced safety. ImmunityBio has entered an exclusive global agreement with the Serum Institute of India to obtain a supply of the BCG vaccine for all types of cancer.

The U.S. Food and Drug Administration (FDA) has authorized ImmunityBio's expanded access program (EAP) to introduce an alternative source of Bacillus Calmette-Guérin (BCG) to address the current supply shortages caused by Tice BCG (1). This development comes as a relief to the medical community, particularly urologists, who have faced challenges treating patients due to limited access to the essential bladder cancer-fighting bacterium.

BCG, initially developed as a live vaccine against tuberculosis, has been a cornerstone of non-muscle invasive bladder cancer (NMIBC) treatment since 1921 (1). NMIBC accounts for approximately 80% of the estimated 80,000 new bladder cancer diagnoses in the U.S. annually (1). Before 2012, Merck & Co. accounted for around 30% to 40% of the overall TICE BCG supply in the U.S. However, after other manufacturers exited the market, the company responded by increasing its production capacity (1).

Despite BCG's prevalence as a global vaccine, the manufacturing complexities required to produce a biologic using benign bacteria have resulted in a persistent supply squeeze (1). ImmunityBio, recognizing the need for an alternative source, entered into an exclusive global agreement with the Serum Institute of India in May 2024 to obtain a supply of BCG for all types of cancer (1).

ImmunityBio's alternative BCG source, rBCG, has shown promising outcomes in European clinical trials. These trials demonstrated enhanced safety and immunogenicity, making it a suitable alternative to Tice BCG (2). The FDA's authorization of ImmunityBio's EAP marks a significant step forward in addressing the current supply shortages and ensuring continued access to effective bladder cancer treatments.

References:
[1] FiercePharma. (2023, January 11). Amid Merck supply squeeze, ImmunityBio and Serum Institute snag FDA blessing for BCG. Retrieved from https://www.fiercepharma.com/manufacturing/amid-merck-supply-squeeze-immunitybio-and-serum-institute-snag-fda-blessing-bcg
[2] ImmunityBio. (2023, January 11). ImmunityBio Announces FDA Authorization of Expanded Access Program for Alternative Source of BCG for All Types of Cancer. Retrieved from https://www.immunitybio.com/news-events/press-releases/immunitybio-announces-fda-authorization-of-expanded-access-program-for-alternative-source-of-bcg-for-all-types-of-cancer