Suzanne B. Merrill, MD, FACS, discusses rBCG and the NMIBC landscape

Expanded access programs (EAPs), such as a recently FDA-authorized EAP in which ImmunityBio is partnering with the Serum Institute of India to provide recombinant BCG (rBCG), are “wonderful opportunities” to open up access to needed medications, according to Suzanne B. Merrill, MD, FACS.

“The Tice BCG shortage is a great example of where we needed an EAP, and now we have one with using what looks like a comparable alternative to our standard of care,” said Merrill, a urologic oncologist with Colorado Urology in Lone Tree.

Merrill said her practice is looking forward to participating in the EAP for rBCG.

“I will tell you, in our practice, we are actually in the process of getting set up for this EAP, and we're really excited to be able to use it for our patients,” she commented.

Merrill also discussed the evolving non–muscle invasive bladder cancer treatment space.

“The landscape for available drugs is just rapidly expanding in non–muscle invasive bladder cancer, and we’re finally catching up to this unmet need of having all not really many alternatives at all for our patients with non–muscle invasive bladder cancer. [What we have found is] stimulating the immune system appears to be key in helping to control this disease and so using viral agents [makes] sense. We know that is 1 way to stimulate the immune response. It is a challenging situation. A lot of new agents that are coming down the pipeline are viral agents, but there are also some, non-viral agents coming down as well as some new delivery systems, of course, with chemotherapy. We're going to have to see how it plays out, because certainly manufacturing biologic drugs definitely poses a challenge for sustainability,” 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