The MHRA has authorised Inqlexzo, a sustained-release intravesical gemcitabine system, for adults with BCG-unresponsive high-risk NMIBC based on SunRISe-1 trial data.
Written By: Fariha Sameen, PharmD
Reviewed By: Pharmacally Editorial Team
The UK Medicines and Healthcare products Regulatory Agency has authorised Inqlexzo, an intravesical delivery system containing gemcitabine, for the treatment of adults with bacillus Calmette-Guérin (BCG)-unresponsive high-risk non-muscle invasive bladder cancer (HR-NMIBC) with carcinoma in situ who are ineligible for, or choose not to undergo, radical cystectomy. The marketing authorisation was granted to Janssen-Cilag Ltd. on June 24, 2026, through the International Recognition Procedure (IRP) Route B.
The approval expands treatment options for patients with limited bladder-preserving alternatives after failure of BCG therapy, where radical bladder removal has traditionally remained the standard treatment.
Sustained Local Gemcitabine Delivery for Bladder Cancer
High-risk non-muscle invasive bladder cancer is confined to the inner layers of the bladder but carries a substantial risk of recurrence and progression to muscle-invasive disease. Patients whose disease no longer responds to BCG therapy often face radical cystectomy, a major surgical procedure that may not be suitable for every patient because of age, comorbidities, or personal preference.
Inqlexzo provides sustained local delivery of gemcitabine directly within the bladder. A healthcare professional inserts the device through a catheter, where it continuously releases the chemotherapy over approximately three weeks before removal by cystoscopy. Treatment is administered every three weeks during the first six months and then every 12 weeks for up to 18 months, or until disease recurrence, progression, or unacceptable toxicity.
Clinical Study Demonstrated Durable Complete Responses
The MHRA based its decision on clinical study data from SunRISe-1 trial (NCT04640623) evaluating the intravesical gemcitabine delivery system in adults with BCG-unresponsive HR-NMIBC with carcinoma in situ.
The study showed that 82% of patients achieved a complete response, while 51% of responders maintained that response for at least 12 months, indicating durable disease control in a population with few effective bladder-sparing treatment options.
The safety profile was consistent with local bladder treatment. The most frequently reported adverse reactions included urinary frequency, urinary tract infection, dysuria, urinary urgency, urinary tract pain, haematuria, and bladder irritation.
MHRA Highlights Ongoing Safety Monitoring
Commenting on the authorisation, Julian Beach, Interim Executive Director of Healthcare Quality and Access at the MHRA, said the approval provides a new treatment option for adults with BCG-unresponsive HR-NMIBC who cannot undergo or choose to avoid bladder removal surgery. He added that the agency will continue to closely monitor the product’s safety and effectiveness following its approval.
The MHRA also encouraged healthcare professionals and patients to report suspected adverse events through the Yellow Card Scheme to support ongoing pharmacovigilance.
Path Forward
The Summary of Product Characteristics (SmPC) and Patient Information Leaflet will be published on the MHRA Products website within seven days of approval. With UK regulatory clearance now in place, Inqlexzo offers an additional bladder-preserving option for patients with BCG-unresponsive high-risk non-muscle invasive bladder cancer who have limited therapeutic choices beyond radical cystectomy.
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About the Writer
Fariha Sameen, PharmD (LinkedIn), is a clinical pharmacy professional with hands-on experience in patient counselling, medication review, therapeutic monitoring, and clinical documentation across multiple departments. She has experience identifying and assessing drug-related problems and supporting medication safety practices. Her interests include pharmacovigilance, ADR reporting, clinical research, and medical writing focused on clear, evidence-based communication.