Opinion
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Eugene Cone, MD, outlines potential impact of Expanded Access Program for rBCG
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“If it is as efficacious as it looks, we will have more patients who are getting effective standard of care treatment, not needing to go on to further treatment, not having recurrences, [having decreased] morbidity from repeated resections, and saving bladders in the process," says Eugene B. Cone, MD.
The FDA recently authorized an Expanded Access Program (EAP; NCT06800963) that will provide recombinant BCG (rBCG) to patients across the US. The program was initiated at U.S. Urology Partners, with 60 additional sites in the process of launching as well.
In a recent interview with Urology Times®, Eugene B. Cone, MD, of Urology of Indiana, an affiliate of U.S. Urology, discussed the potential impacts that this program may have in addressing the BCG shortage.
The program plans to enroll 100 participants with non–muscle invasive bladder cancer to assess clinical outcomes and safety with rBCG. If these both appear to be promising, Cone explained, ImmunityBio has the capacity for a larger scale launch on the market.
“It will have a very immediate impact if they do get approval to bring this to the market across the board, because it could potentially at least alleviate and potentially fix the BCG shortage, so patients would get access to BCG,” Cone said. “If it is as efficacious as it looks, we will have more patients who are getting effective standard of care treatment, not needing to go on to further treatment, not having recurrences, [having decreased] morbidity from repeated resections, and saving bladders in the process.”
However, Cone noted some potential downstream effects as well. For example, he explained that if rBCG poses a cheaper option, newer therapies coming down the pike may face obstacles in getting access to the market or in reaching patients in the BCG-naïve setting.
