The Medicines and Healthcare products Regulatory Agency (MHRA) has granted approval for an intravesical delivery system containing gemcitabine (Inqlexzo) aimed at treating adults with specific types of bladder cancer who are either ineligible for or have opted against radical cystectomy.
Understanding High-Risk Non-Muscle Invasive Bladder Cancer
High-risk non-muscle invasive bladder cancer (HR-NMIBC) refers to a variant of bladder cancer that, while not having invaded the muscle layer of the bladder, presents a significant chance of recurrence or progression.
This innovative intravesical delivery system is administered by a healthcare professional using a catheter, allowing for localised and sustained release of gemcitabine over a period of approximately three weeks before it is removed via cystoscopy. Patients will receive treatments every three weeks for the initial six months, followed by sessions every 12 weeks for up to 18 months, or until there is evidence of disease recurrence, progression, or intolerable side effects.
Expert Insights on the New Treatment
Julian Beach, the MHRA’s Interim Executive Director of Healthcare Quality and Access, expressed his satisfaction with the approval, stating:
“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.”
He further assured that, as with all new medical products, the agency will remain vigilant in monitoring the safety and effectiveness of this system.
Clinical Study Findings and Adverse Reactions
The authorisation is bolstered by findings from a clinical study that assessed the intravesical delivery system in adults suffering from BCG-unresponsive HR-NMIBC with carcinoma in situ. The study revealed that 82% of participants achieved a complete response, with 51% of those maintaining their response for at least 12 months.
However, patients should be aware of potential adverse reactions, which commonly include urinary frequency, urinary tract infections, dysuria (painful urination), urinary urgency, bladder pain, haematuria (blood in urine), and bladder irritation.
Ongoing Safety Monitoring and Reporting
The MHRA will continue to closely scrutinise the safety and effectiveness of this intravesical system. Individuals who suspect they may be experiencing side effects are encouraged to consult their healthcare professional and report any concerns through the MHRA Yellow Card scheme.
Additional Information and Regulatory Framework
These new marketing authorisations were granted on 24 June 2026 to Janssen-Cilag Ltd, following submission and approval through the International Recognition Procedure (IRP) Route B.
Comprehensive information will soon be available in the Summary of Product Characteristics and Patient Information leaflets, which are expected to be published on the MHRA Products website within seven days of approval.
The MHRA plays a crucial role in regulating all medicines and medical devices in the UK, ensuring their effectiveness and safety. The agency’s operations are founded on robust, fact-based assessments to ensure that the advantages of any product outweigh its associated risks.
As an executive agency of the Department of Health and Social Care, the MHRA is committed to safeguarding public health.
For media inquiries, please reach out via email at newscentre@mhra.gov.uk or call 020 3080 7651.
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