Inqlexzo authorised for BCG-unresponsive high-risk non-muscle invasive bladder cancer
- Sponsor
- Janssen-Cilag Ltd
- Drug
- Inqlexzo · gemcitabine (intravesical delivery system)
- Indication
- BCG-unresponsive high-risk non-muscle-invasive bladder cancer
MHRA authorised Inqlexzo, an intravesical gemcitabine-releasing device, for adults with high-risk non-muscle-invasive bladder cancer (HR-NMIBC) that has not responded to standard BCG therapy. The device delivers gemcitabine continuously to the bladder over ~3 weeks and is positioned for patients ineligible for — or declining — radical cystectomy.
Read original at gov.uk ↗From the source
MHRA authorises gemcitabine delivery system for adults with BCG- unresponsive high-risk non-muscle invasive bladder cancer
From: Medicines and Healthcare products Regulatory Agency Published: 1 July 2026
The Medicines and Healthcare products Regulatory Agency (MHRA) has authorised an intravesical delivery system containing gemcitabine (Inqlexzo) for the treatment of adults for certain types of bladder cancer who are ineligible for — or have chosen not to undergo — radical cystectomy.
High-risk non-muscle invasive bladder cancer (HR-NMIBC) is a form of bladder cancer that has not spread into the muscle layer of the bladder but has a high risk of recurring or progressing.
As with any medicinal product, the MHRA will keep the safety and effectiveness of the intravesical delivery system containing gemcitabine under close review.
Reproduced from MHRA News · view original · public domain or open-licensed government work