How recombinant BCG could ease strain of supply issues

For years, urologists and patients have dealt with the effects of the BCG shortage. A new expanded access program (EAP) authorized by the FDA, in which ImmunityBio is partnering with the Serum Institute of India to provide recombinant BCG (rBCG), seeks to alleviate the effects of the current shortage.¹

In an interview with Urology Times®, Suzanne B. Merrill, MD, FACS, discussed the impact of the BCG shortage.

“I think for all of us, across the world, the BCG shortage has greatly affected both practices and patients. Certainly, in our practice, we've had to undergo operational changes to ensure a better stewardship and correct allocation of this vital resource. It's definitely affected treatment decisions for our patients—whether or not to perform maintenance…Sometimes, patients have been shifted from using the standard of care BCG to potentially a chemotherapy agent, and so allowing the opportunity to investigate an alternative agent like recombinant BCG, I think, is a great opportunity to release the strain on our supply issues, and expand access, again, to what looks like a very comparable alternative to our standard of care Tice BCG. Again, it’s still yet to be fully vetted, but it looks very promising. I'm all for this great effort by ImmunityBio to provide us with an alternative option,” said Merrill, a urologic oncologist with Colorado Urology in Lone Tree.

When asked whether rBCG represents a paradigm shift, Merrill said time will tell.

“I think it's still yet to be determined if this is going to be a paradigm shift, as we just need more data. We need to understand a little bit better the safety and tolerability, which this EAP is going to address. We need a little bit better understanding if this genetically modified variation is going to prove to have maybe superior qualities, whether it's from an adverse event aspect, or potentially improved immunogenicity and better efficacy,” Merrill said.

REFERENCE

1. FDA authorizes ImmunityBio to provide recombinant BCG (rBCG) to urologists to address TICE BCG shortage. News release. ImmunityBio. February 19, 2025. Accessed February 19, 2025. https://ir.immunitybio.com/news-releases/news-release-details/fda-authorizes-immunitybio-provide-recombinant-bcg-rbcg