Opinion
Video
Chad Reichard, MD, on the Expanded Access Program for recombinant BCG
Author(s):
"This certainly does feel like the beginning of the light at the end of the tunnel coming out of the BCG shortage," says Chad A. Reichard, MD.
The FDA recently authorized an Expanded Access Program (EAP) that will provide recombinant BCG (rBCG) to patients across the US. The program, implemented through a partnership between ImmunityBio and the Serum Institute of India, is intended to address the ongoing BCG shortage by providing an alternative source of the therapy for patients with bladder cancer.
In a recent interview with Urology Times®, Chad A. Reichard, MD, shared his thoughts on how the EAP may have an impact on the shortage. Reichard is a urologist at Urology of Indiana, an affiliate of US Urology Partners, which recently became the first site to launch the EAP in the US.
Currently, there are 60 sites that are in the process of launching.
According to Dr. Reichard, the EAP feels like the start of the “light at the end of the tunnel” in regard to addressing the BCG shortage. The shortage, which ramped up in 2019, has posed challenges for the treatment of patients with non–muscle invasive bladder cancer, for which BCG has been the standard of care since 1977.
Dr. Reichard expressed hope that this program will pave the way for widespread usage of alternative strains of BCG across the US.
