MHRA authorises gemcitabine delivery system for adults with BCG-unresponsive high-risk non-muscle invasive bladder cancer
As with any medicinal product, the MHRA will keep the safety and effectiveness of the intravesical delivery system containing gemcitabine under close review.
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.
The intravesical delivery system containing gemcitabine is placed into the bladder by a healthcare professional using a catheter. The system provides sustained local release of gemcitabine over approximately three weeks before being removed by cystoscopy. Treatment is administered every three weeks for the first six months, followed by every 12 weeks for up to 18 months, or until disease recurrence, progression or unacceptable toxicity.
Julian Beach, MHRA Interim Executive Director of Healthcare Quality and Access, said:
We are pleased to approve the intravesical delivery system containing gemcitabine as a new treatment option for adults with BCG-unresponsive high-risk non-muscle invasive bladder cancer who are unable or choose not to undergo bladder removal surgery.
As with any new product, we will continue to monitor the safety and effectiveness of this intravesical system closely.
The authorisation is supported by results from a clinical study, which evaluated the intravesical delivery system containing gemcitabine in adults with BCG-unresponsive HR-NMIBC with carcinoma in situ. In the study, 82% of patients achieved a complete response, with 51% of responders maintaining their response for at least 12 months.
The most reported adverse reactions included urinary frequency, urinary tract infection, painful urination (dysuria), urinary urgency, urinary tract pain, blood in the urine (haematuria) and bladder irritation.
As with any medicine, the MHRA will keep the safety and effectiveness of this system under close review. Anyone who suspects they have experienced a side effect should speak to their healthcare professional and report it via the MHRA Yellow Card scheme.
Notes to editors:
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These new marketing authorisations were granted on 24 June 2026 to Janssen-Cilag Ltd.
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This product was submitted and approved via the International Recognition Procedure (IRP) Route B.
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More information can be found in the Summary of Product Characteristics and Patient Information leaflets which will be published on the MHRA Products website within 7 days of approval.
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The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
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The MHRA is an executive agency of the Department of Health and Social Care.
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For media enquiries, please contact the newscentre@mhra.gov.uk, or call on 020 3080 7651.