MHRA Approves ImmunityBio’s ANKTIVA For Use With BCG In Bladder Cancer

ImmunityBio has received its first international regulatory approval for ANKTIVA® (nogapendekin alfa inbakicept-pmln) from the UK Medicines and Healthcare products Regulatory Agency (MHRA). The marketing authorization covers the use of ANKTIVA in combination with Bacillus Calmette-Guérin (BCG) for the treatment of certain bladder cancer patients. ANKTIVA is a first-in-class IL-15 agonist designed to activate NK and T cells, restoring immune function compromised by cancer and prior therapies.

“With the MHRA’s authorization of ANKTIVA plus BCG, we can now offer our immunotherapy outside the U.S. to help patients with a disease that, if not effectively treated, can lead to bladder removal. This immune-boosting, lymphocyte-stimulating agent, the first of its kind, is central to our Cancer BioShield platform, which is designed to restore immune function and support long-term disease control,” said Dr. Patrick Soon-Shiong, Founder, Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio.

The approval follows promising data from a multicenter trial involving 77 patients with non-muscle invasive bladder cancer who received ANKTIVA plus BCG. Some patients demonstrated complete responses that extended beyond 47 months, with durations of response surpassing 24 months, an outcome deemed clinically meaningful by the International Bladder Cancer Group. The agent had already secured Breakthrough Therapy designation from the U.S. FDA, which also approved it earlier.

“ImmunityBio is honored to have received this important authorization from the UK MHRA. In light of the United States Most-Favored-Nation Prescription Drug Pricing policy implemented on May 12, 2025, we are actively evaluating our go-to-market strategy for the UK,” said Richard Adcock, CEO and President of ImmunityBio.

Following its UK approval, ImmunityBio has submitted regulatory applications to the European Medicines Agency (EMA) to extend access to ANKTIVA across EU member states and associated countries. The company emphasizes ANKTIVA’s unique mechanism for restoring immunocompetence and its ability to be monitored through routine blood tests.