The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved Serum Life Science Europe’s nogapendekin alfa inbakicept, known commercially as Anktiva, for adults with non-muscle invasive bladder cancer unresponsive to BCG immunotherapy.
This condition is characterised by the disease being confined to the bladder’s inner lining and may include tumours.
BCG, or Bacillus Calmette-Guérin, is a standard treatment aimed at stimulating an immune response directly in the bladder. However, a subset of patients does not respond to this treatment, resulting in limited alternatives.
The approval of nogapendekin alfa inbakicept was facilitated through the International Recognition Procedure (IRP), which enables the MHRA to leverage the expertise and decisions of trusted international regulatory partners to benefit UK patients.
The drug is administered in combination with BCG via a liquid solution delivered into the bladder through a catheter.
Detailed information on side effects is available in the Patient Information Leaflet and the Summary of Product Characteristics, accessible on the MHRA website within a week of approval.
Serum Life Science Europe received the approval on 4 July 2025. The MHRA’s approval process under the IRP involves a targeted assessment, with the agency retaining the authority to reject applications if the supporting evidence is deemed insufficient.
Serum Life Science Europe, originally founded as Vakzine Projekt Management in August 2002, was established under the German Federal Ministry of Education and Research’s initiative to advance vaccine development.
The company has developed five products, focusing on three key candidates: VPM1002BC, an immunotherapeutic for bladder cancer; VPM1002, a novel tuberculosis vaccine candidate; and VPM2001, a vaccine targeting cytomegalovirus.
