LONDON, July 8, 2025 — The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted approval for ANKTIVA® (nogapendekin alfa inbakicept-pmln) in combination with BCG for the treatment of certain types of bladder cancer.
The decision marks a key milestone for both ImmunityBio, the drug’s developer, and the broader UK biotech sector.
A New Option for Non-Muscle Invasive Bladder Cancer (NMIBC)
The therapy is now authorized for use in patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ, a form of bladder cancer that has not invaded the muscle layer but is resistant to the standard BCG treatment.
ANKTIVA® is an immunotherapy designed to activate natural killer (NK) and T cells, working alongside BCG (Bacillus Calmette-Guérin) to boost the body’s immune response against bladder cancer cells.
UK Among First to Approve
The UK becomes one of the first countries in Europe to approve the combination treatment, following similar regulatory progress in the United States. The approval was granted under MHRA’s Innovation Passport and Project Orbis, which accelerates review of promising oncology drugs through global collaboration.
What It Means for Patients
This approval offers a new option for bladder cancer patients who have limited treatment alternatives once BCG fails. Previously, radical cystectomy (surgical removal of the bladder) was often the only remaining option.
ImmunityBio has stated that it plans to work with NHS authorities to ensure access and affordability across eligible UK cancer centers.