Adstiladrin(nadofaragene firadenovec)

Oncology· 689 cited findings· 1 source document

Company: Ferring A S

What the regulatory reviews say

Adstiladrin (nadofaragene firadenovec) is indicated for the treatment of adult patients with high-grade (HG), Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC). The application for this drug was submitted on 22 November 2024, with a request for conditional marketing authorization and new active substance status.

In efficacy studies, the incidence of Complete Response (CR) at any time was 53.4%, with a lower bound of the 95% confidence interval at 43.3%. The median Duration of Complete Response (DoCR) was 9.72 months. The durability of complete response was 45.5% at Month 12, decreasing to 20.0% at Month 48. High-grade recurrence-free survival with a positive immunogenic response at Month 3 was 77.7%, and 52% of patients remained high-grade recurrence-free at Month 12. Conversely, 48% of patients experienced high-grade recurrence or disease progression at or before Month 12.

Regarding safety, systemic exposure to rAd-IFN-derived DNA was observed in 1 out of 23 patients in a Phase 2 study. Vector-derived DNA was detected in the urine of 100% of patients at Month 1 Day 2, decreasing to 13% at Month 4 Day 1. The mortality risk within 90 days of radical cystectomy, a comparator procedure, is estimated at 3 to 5%.

Key figures — cited to the source page

Incidence of Complete Response (CR) at any time	53.4	Ferring A S — Adstiladrin EMA EPAR public assessment report, p.73
Median Duration of Complete Response (DoCR)	9.72	Ferring A S — Adstiladrin EMA EPAR public assessment report, p.74
Durability of complete response at Month 12	45.5	Ferring A S — Adstiladrin EMA EPAR public assessment report, p.74
High-grade-recurrence-free survival with positive immunogenic response (Month 3)	77.7	Ferring A S — Adstiladrin EMA EPAR public assessment report, p.53
Patients remaining high-grade recurrence-free at Month 12	52	Ferring A S — Adstiladrin EMA EPAR public assessment report, p.53
Patients with high-grade recurrence or disease progression at or before Month 12	48	Ferring A S — Adstiladrin EMA EPAR public assessment report, p.53
Systemic exposure to rAd-IFN-derived DNA (Phase 2)	1	Ferring A S — Adstiladrin EMA EPAR public assessment report, p.52
Mortality risk within 90 days of radical cystectomy	3 to 5	Ferring A S — Adstiladrin EMA EPAR public assessment report, p.11

Source documents

Ferring A S — Adstiladrin EMA EPAR public assessment report (EMEA/H/C/005856, 2026) (2026)

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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.