The National Comprehensive Cancer Network (NCCN) has upgraded its recommendation for nadofaragene firadenovec-vncg to Category 2A for patients with BCG-unresponsive, non-muscle invasive bladder cancer who have high-grade papillary tumors (Ta/T1) without carcinoma in situ (CIS). This aligns the guidance for papillary-only disease with the existing recommendation for patients with CIS. The therapy is FDA-approved for NMIBC with CIS and is given as a non-replicating gene therapy intravesically every three months.
Long-term data from a Phase 3 trial of 157 patients support the update. At 57 months, recurrence-free survival was 33% in the papillary-only group and 13% in the CIS group. The treatment also allowed bladder preservation, with 60-month cystectomy-free survival of 59% for Ta/T1 patients and 43% for CIS patients. Overall survival remained high at 60 months, with rare progression to muscle-invasive disease.
These findings indicate that nadofaragene firadenovec offers a durable, bladder-sparing option for high-risk NMIBC patients who do not respond to standard BCG therapy, providing an alternative to radical cystectomy.