The Medicines and Healthcare products Regulatory Agency (MHRA)
has today, 4 July 2025, approved nogapendekin alfa inbakicept
(Anktiva) for adults with BCG-unresponsive non-muscle invasive
bladder cancer, where the disease remains confined to the inner
lining of the bladder and may include tumours.
BCG (Bacillus Calmette-Guérin) is a standard immunotherapy for
early-stage bladder cancer, delivered directly into the bladder
to stimulate an immune response. However, some patients do not
respond to BCG, leaving limited treatment options.
This medicine has been approved through the International
Recognition Procedure (IRP). The IRP allows the MHRA to consider
the expertise and decision-making of trusted regulatory partners
for the benefit of UK patients.
Nogapendekin alfa inbakicept mixed with BCG is administered via a
liquid that is diluted and then delivered into the bladder
through a catheter inserted into the urethra.
A full list of side effects can be found in the Patient
Information Leaflet (PIL) or the Summary of Product
Characteristics (SmPC), available on the MHRA website within 7
days of approval.
As with any medicine, the MHRA will keep the safety and
effectiveness of nogapendekin alfa inbakicept under close
review.
Anyone who suspects they are having a side effect from this
medicine is encouraged to talk to their doctor, pharmacist or
nurse and report it directly to the MHRA Yellow Card scheme,
either through the website (https://yellowcard.mhra.gov.uk/)
or by searching the Google Play or Apple App stores for MHRA
Yellow Card.
ENDS Notes to
editors
-
The approval was granted on 4 July 2025 to Serum Life Science
Europe GmbH
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This product was submitted and approved via the International
Recognition Procedure.
-
The MHRA conducts a targeted assessment of IRP applications
and retains the authority to reject applications if the
evidence provided is not considered sufficiently
robust.
-
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.
