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.
Notes
- The approval was granted on 4 July 2025 to Serum Life Science Europe GmbH
- 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.
- 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.
- The MHRA is an executive agency of the Department of Health and Social Care.
source: GOV
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