Eligible patients will now have access to the first FDA-approved intravesical gene therapy for non-muscle invasive bladder cancer (NMIBC) at Fox Chase Cancer Center.
Rosalia Viterbo, MD, FACS
The therapy, called Adstiladrin (nadofaragene firadenovec-vncg), is approved for patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive NMIBC with carcinoma in situ with or without papillary tumors. Adstiladrin is a non-replicating adenovirus vector-based therapy containing the gene interferon alfa-2b.
“The treatment is instilled in the bladder and delivers a copy of the human-encoding interferon alfa-2b protein,” explained Rosalia Viterbo, MD, FACS, Associate Professor, Department of Urology, at Fox Chase and a Fox Chase-Temple Urologic Institute Provider. “This results in cell transduction and local expression of interferon alfa-2b, which is a protein that has anti-tumor effects.”
Unlike other treatment options for this patient population that require six weekly administrations plus maintenance, Adstiladrin is administered by catheter into the bladder once every three months.
Andres D. Correa, MD,
Andres D. Correa, MD, Assistant Professor and Director of Research in the Department of Urology at Fox Chase and a Fox Chase-Temple Urologic Institute Provider, explained that there has been increased interest in new and effective treatments for patients with BCG-unresponsive NMIBC that would allow patients to avoid bladder removal. In a phase-3 clinical trial of Adstiladrin, more than half of patients with NMIBC carcinoma in situ had complete response to the treatment and almost half of these responses were maintained at one year.
Fox Chase is the first cancer center in the region offering access to this treatment as standard of care. “This will include primarily patients that have carcinoma in situ but also patients that cannot tolerate gemcitabine docetaxel, an alternative treatment for unresponsive NMIBC,” Dr. Correa said.
Christine L. Amoroso, BSN, RN, OCN
Fox Chase is uniquely positioned to provide this groundbreaking therapy, according to Christine L. Amoroso, BSN, RN, OCN, ONCC, a member of Fox Chase’s Urologic Oncology team, who helps run its dedicated intravesical clinic.
“I don’t think many other institutions can compare with the volume of patients we treat intravesically,” Amoroso said.
This dedicated intravesical clinic provides Fox Chase with the expertise and infrastructure to safely and effectively administer Adstiladrin.
Once thawed, Adstiladrin must be used within 24 hours, and once it is in the syringe, it must be administered within a short time frame. Patients must then lie flat for an hour and rotate or change position every 15 minutes. The therapy also has stringent requirements related to the way it is eliminated from the bladder.
“It is a bit labor intensive, but it is within our wheelhouse because of all the treatments we already do,” Amoroso said.
Dr. Correa said that any patient who meets the requirement for being BCG-unresponsive should be referred to Fox Chase to talk about eligibility for this medication.