Ferring A S — Adstiladrin EMA EPAR public assessment report (EMEA/H/C/005856, 2026)
Ferring A S · 2026 · EMA EPAR public assessment report
Report summary
The EMA has granted conditional marketing authorization for Ferring Pharmaceuticals' Adstiladrin (nadofaragene firadenovec) for high-grade, BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). The gene therapy, delivered via an adenoviral vector, demonstrated a significant complete response rate in pivotal Phase 3 study CS-003, addressing an unmet medical need. Quality aspects, non-clinical studies, and environmental risk assessments were satisfactorily resolved. While efficacy is promising, the single-arm trial design necessitates further long-term safety and efficacy data from the ongoing ABLE-22 study, due by March 2029, to confirm the benefit-risk balance.
Key findings — cited to the page
| High-Grade Recurrence-Free Survival (HG RFS) at Month 12 | 35.0 % | CS-002 · p.91 |
| High-Grade Recurrence-Free Survival (HG RFS) at Month 3 | 68.4 % | CS-002 · p.91 |
| Patients with high-grade recurrence or disease progression at or before Month 12 (rAd-IFN-CS-003, post-hoc analysis) | 48 % | · p.53 |
| Incidence of high-grade recurrence-free survival at Month 12 (Total) | 30.5 % | Study CS-003 · p.76 |
| High-Grade Recurrence-Free Survival (HG RFS) at Month 12 | 36.8 % | CS-002 · p.91 |
| High-Grade Recurrence-Free Survival (HG RFS) at Month 3 | 47.6 % | CS-002 · p.91 |
| High-grade-recurrence-free survival with positive immunogenic response (rAd-IFN-CS-003, Month 3) | 77.7 % | · p.53 |
| Patients remaining high-grade recurrence-free at Month 12 (rAd-IFN-CS-003, post-hoc analysis) | 52 % | · p.53 |
| Incidence of high-grade recurrence-free survival at Month 12 (CIS) | 24.3 % | Study CS-003 · p.76 |
| Incidence of high-grade recurrence-free survival at Month 12 (Papillary Disease) | 43.8 % | Study CS-003 · p.76 |
| High-Grade Recurrence-Free Survival (HG RFS) at Month 12 | 33.3 % | CS-002 · p.91 |
| High-Grade Recurrence-Free Survival (HG RFS) at Month 3 | 57.5 % | CS-002 · p.91 |
Source: Ferring A S ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Oncology library →