CHMP adopts positive opinion for Adstiladrin (nadofaragene firadenovec) in non-muscle invasive bladder cancer – Ferring
The EMA’s CHMP adopted a positive opinion, recommending the granting of a conditional marketing authorisation for the medicinal product Adstiladrin. Since Adstiladrin is an advanced therapy medicinal product, the CHMP positive opinion is based on an assessment by the Committee for Advanced Therapies. The applicant is Ferring Pharmaceuticals A/S. Adstiladrin is indicated as monotherapy for the treatment of adult patients with Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumours. Adstiladrin will be available as a 3 x 1011 viral particles/ml intravesical suspension.
The benefits of Adstiladrin are a 53.4% (95% CI: 43.3, 63.3) complete response rate with a median duration of response of 9.7 months in the target population (n=103) in a single‑arm, open‑label, multicentre pivotal study. The most common side effects with Adstiladrin are instillation site discharge, bladder spasm, micturition urgency, haematuria, dysuria, urinary tract infection, lower urinary tract pain, pollakiuria, fatigue, pyrexia, chills, headache and diarrhoea.
Detailed recommendations for the use will be described in the summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after the marketing authorisation has been granted by the European Commission.
