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.
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:
-
These new marketing authorisations were granted on 24 June
2026 to Janssen-Cilag Ltd.
-
This product was submitted and approved via the International
Recognition Procedure (IRP) Route B.
-
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.
