Suzanne B. Merrill, MD, FACS, on EAP program for recombinant BCG

An expanded access program (EAP) to provide recombinant BCG (rBCG) in the US was recently authorized by the FDA.¹

For the EAP, ImmunityBio has partnered with the Serum Institute of India, which develops rBCG, to provide an alternative source across the US. In an interview with Urology Times®, Suzanne B. Merrill, MD, FACS, provided an overview of the EAP.

“One important aspect to get across…is that access to this EAP is pretty easy. What one would do is go to the ImmunityBio website. You could even just put in search terms [such as], “ImmunityBio,” “rBCG,” “recombinant BCG,” and you'll get to a place on their website where the practice can register: put in the provider's name, practice name, the reason for need for recombinant BCG, and then that will go to Anova, and Anova will review that and get back to you, usually within a quick turnaround time point. And ultimately, once Anova gets back to that practice, then they help to set up as this is a clinical trial reporting to the FDA safety data on the use of recombinant BCG in any patient that provider deems eligible for TICE BCG, but [for whom] they cannot or do not have access to the standard of care TICE BCG,” said Merrill, a urologic oncologist with Colorado Urology in Lone Tree.

In the interview, Merrill also summarized rBCG.

“Recombinant BCG is a live but genetically modified BCG, which is derived from the Prague strain, and we use what is approved in the US, the Tice BCG strain. Now, Prague is reportedly a less virulent BCG strain and is associated with a better safety and tolerability profile due to a deletion of the phoP gene. It has 2 gene modifications that ultimately lead to what looks like an improved immunogenicity with CD8 and CD4 T cell stimulation, and also potentially an improved safety profile compared with earlier strains,” 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