The Medicines and Healthcare products Regulatory Agency (MHRA) has given its approval for a novel intravesical delivery system containing gemcitabine, marketed as Inqlexzo. This new treatment is specifically for adults diagnosed with BCG-unresponsive high-risk non-muscle invasive bladder cancer (HR-NMIBC) who are either ineligible for, or have opted against, radical cystectomy – the surgical removal of the bladder.
HR-NMIBC is a form of bladder cancer that has not yet spread into the bladder's muscle layer but carries a significant risk of recurrence or progression. The approval of Inqlexzo, granted to Janssen-Cilag Ltd on 24 June 2026, marks a notable development for patients facing limited treatment alternatives.
The delivery system involves a healthcare professional inserting the device into the bladder using a catheter. Once in place, it provides a sustained, local release of gemcitabine over approximately three weeks before being removed via cystoscopy. Treatment is structured with administrations every three weeks for the initial six months, followed by a maintenance phase of every 12 weeks for up to 18 months, or until the disease recurs, progresses, or unacceptable side effects occur.
Julian Beach, MHRA Interim Executive Director of Healthcare Quality and Access, welcomed the authorisation, stating that it provides a crucial new option for patients with this challenging condition. He also confirmed that the MHRA would continue to closely monitor the safety and effectiveness of the system, consistent with their oversight of all new medicinal products.
The authorisation is supported by data from a clinical study involving adults with BCG-unresponsive HR-NMIBC with carcinoma in situ. The study reported that 82% of patients achieved a complete response, with 51% of those responders maintaining their response for at least 12 months. Common adverse reactions reported included increased urinary frequency, urinary tract infections, painful urination (dysuria), urinary urgency, urinary tract pain, blood in the urine (haematuria), and bladder irritation.