People suffering from BCG-unresponsive non-muscle invasive bladder cancer now have a new hope with the recent approval of the Medicines and Healthcare Products Regulatory Agency (MHRA) of the new medication Nogapendekin Alfa Inbakicept (Anktiva).
Bacillus Calmette-Guérin (BCG) is the established immunotherapy for early-stage bladder cancer, administered directly into the bladder to stimulate an immune response. Despite its effectiveness, some patients do not respond adequately, leaving them with limited treatment alternatives.
Anktiva has been approved through the International Recognition Procedure (IRP). The IRP enables the MHRA to draw on the expertise and regulatory decisions of trusted international partners, supporting faster access to innovative therapies for patients in the UK.
Nogapendekin alfa inbakicept, when used in combination with BCG, is prepared as a diluted liquid and administered directly into the bladder. The treatment is delivered through a catheter inserted into the urethra, ensuring the medicine reaches the targeted site of action.
Comprehensive information on side effects can be found in the Patient Information Leaflet (PIL) and the Summary of Product Characteristics (SmPC), both available on the MHRA website. The MHRA will continue to closely monitor the safety of this product, and individuals who experience any side effects are advised to consult their doctor, pharmacist, or nurse and report them directly through the MHRA Yellow Card scheme.
