On 24 June 2026 the Medicines and Healthcare products Regulatory Agency authorised the intravesical delivery system containing gemcitabine (Inqlexzo) for adults with BCG‑unresponsive high‑risk non‑muscle invasive bladder cancer who cannot or choose not to undergo radical cystectomy. The system is inserted into the bladder by a healthcare professional using a catheter and releases gemcitabine over about three weeks. Treatment is given every three weeks for six months, then every 12 weeks for up to 18 months or until disease recurrence, progression or unacceptable toxicity. A clinical study showed 82 % of patients achieved a complete response, with 51 % maintaining response for at least 12 months. Reported side effects include urinary frequency, infection, dysuria, urgency, haematuria and bladder irritation. The MHRA will continue to monitor safety and effectiveness.
© Crown copyright, 2024, GOV.UK.
Summary adapted from content licensed under the Open Government Licence v3.0.
For details, see https://www.nationalarchives.gov.uk/doc/open-government-licence/version/3/.
Original source: https://www.gov.uk/
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