The first patients with bladder cancer has been dosed with recombinant Bacillus Calmette-Guérin (rBCG) following the current shortage of TICE® BCG in the United States, according to a news release from ImmunityBio, Inc.
“The shortage of BCG has real consequences, especially in many rural communities across the country where supply shortages have impacted the treatment of patients with bladder cancer,” Dr. Christopher M. Pieczonka. “I’m pleased U.S. Urology is at the forefront of offering rBCG and would like to thank ImmunityBio for their initiative to seek and secure authorization from the [Food and Drug Administration] for expanded access to this vital BCG alternative.”
Pieczonka is chief executive officer and director of Clinical Research at Associated Medical Professionals, an affiliate of U.S. Urology Partners.
U.S. Urology Partners is among the first providers to offer ImmunityBio’s recombinant rBCG following the U.S. FDA’s recent authorization of the company’s Expanded Access Program (EAP). According to the official U.S. FDA website, fda.gov, the EAP, also referred to as “Compassionate Use”, serves as a potential pathway for a patient with a serious or life-threatening disease to have access to an investigational medical product. Treatment with this product is done so outside of clinical trials when no comparable or satisfactory alternative therapy options are available.
The approval aims to address ongoing shortages of BCG, a critical standard-of-care treatment for bladder cancer, by providing an alternative option for these individuals. Multiple urology centers nationwide are currently working to activate their sites for rBCG administration.
A shortage of TICE BCG in the U.S. is hindering bladder cancer treatment, according to the release. A Sermo survey of 100 U.S. urologists found that 57% of them were unable to treat patients with the therapy in the past year due to limited access.
In European bladder cancer clinical trials, the recombinant BCG vaccine showed strong immunogenicity with CD8+ and CD4+ T cell stimulation and improved safety over earlier BCG strains and formulations.
“This is an incredibly exciting opportunity to expand the BCG supply to allow more patients to receive the full course of their cancer treatment, saving bladders and extending lives,” Dr. Eugene B. Cone, co-director of Clinical Research at Urology of Indiana, an affiliate of U.S. Urology, said in the release.
BCG, a benign bacterium, is derived from the Mycobacterium bovis Bacillus Calmette-Guérin strain, according to the release. Since 1977, intravesical instillation of BCG has been the standard of care for non-muscle invasive bladder cancer, inducing an immune response that clears cancer cells. rBCG completed phase 1/2 trials in Europe, showing tolerance and a safety profile similar to placebo.
Clinical trials support rBCG as a potential TB vaccine, according to the news release. Additional research assessed rBCG’s impact on TB recurrence and its role in susceptibility or severity of respiratory diseases during the SARS-CoV-2 pandemic. BCG remains one of the most widely used vaccines worldwide. However, as a biologic drug derived from benign bacteria, it presents manufacturing challenges.
“Constrained BCG supply has improved stewardship of a limited resource but has come at a high cost to our patients,” said Dr. Chad Reichard, co-director of Clinical Research at Urology of Indiana. “rBCG represents a long overdue potential alternative but does not abrogate responsibility to ongoing diligence and discipline in BCG delivery.”
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