How rBCG EAP could open up access for Anktiva in bladder cancer

ImmunityBio has been awarded patents for the combination of BCG plus nogapendekin alfa inbakicept (Anktiva) in bladder cancer. In a recent interview with Urology Times®, Suzanne B. Merrill, MD, FACS, was asked how she foresees the integration of this combination therapy, alongside the availability of recombinant BCG, influencing future treatment paradigms for non–muscle invasive bladder cancer.

Merrill said, “I feel a lot of providers, with Antiva being available, have unfortunately reserved use of this great FDA-approved agent for BCG-unresponsive patients because of the supply issue with BCG. [In] our practice, I know myself and a lot of my colleagues have felt the need to reserve our critical supply of BCG to those who are BCG naive and just starting their journey with non–muscle invasive bladder cancer, rather than allocate this short-supply drug to our BCG-unresponsive patients. Again, that's where Anktiva is FDA approved now, so when we look at treating our BCG-unresponsive patients, thankfully, now we do have a couple of agents [that are] FDA approved that we can choose from, one of which is Anktiva.” Merrill is a urologic oncologist with Colorado Urology in Lone Tree.

With the recent FDA-authorized expanded access program to provide recombinant BCG in the US, Merrill said this reasoning for not using Anktiva “is taken out.”

“Ultimately, I think it is going to at least allow us in our practice to now consider Anktiva alongside the other FDA-approved agents such as nadofaragene [firadenovec] [Adstiladrin], docetaxel and gemcitabine, and pembrolizumab [Keytruda], for example, on a more even playing field—as it should have been.”

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