UK Approves ANKTIVA for Bladder Cancer Treatment

ImmunityBio's ANKTIVA has received UK approval for treating bladder cancer patients in combination with BCG. This is the first approval outside the US for the lymphocyte-stimulating agent, which was designated a Breakthrough Therapy by the FDA. ANKTIVA has shown safety and efficacy in complete response and duration of response outcomes. ImmunityBio has submitted applications to the European Medicines Agency to expand availability across EU member states.

ImmunityBio Inc. (IBRX) has received a significant milestone with the UK Medicines and Healthcare products Regulatory Agency (MHRA) granting marketing authorization for ANKTIVA (nogapendekin alfa inbakicept-pmln) in combination with Bacillus Calmette-Guérin (BCG) for the treatment of certain bladder cancer patients. This approval marks the first time ANKTIVA, a novel lymphocyte-stimulating agent, is available outside the United States. The drug was designated a Breakthrough Therapy by the FDA and has demonstrated safety and efficacy in clinical trials [1].

ANKTIVA, a first-in-class IL-15 agonist, works synergistically with BCG to activate and proliferate natural killer (NK) and T cells, helping to eliminate cancer cells. The combination therapy offers a new option for eligible patients among the 16,400 to 18,000 people diagnosed with non-muscle invasive bladder cancer (NMIBC) in the UK each year [2]. ImmunityBio has also submitted regulatory applications to the European Medicines Agency (EMA) to expand the availability of ANKTIVA across the 27 European Union (EU) member states, as well as Iceland, Norway, and Liechtenstein.

Dr. Patrick Soon-Shiong, Founder, Executive Chairman, and Global Chief Scientific and Medical Officer of ImmunityBio, stated, "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." Richard Adcock, CEO and President of ImmunityBio, added, "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" [2].

ANKTIVA, which activates and proliferates NK cells, CD4+ and CD8+ T cells, is designed to restore immune competence by reversing lymphopenia, a condition where cancer and conventional therapies reduce the number and function of immune cells. The drug has shown extended duration of complete responses beyond 24 months in clinical trials, surpassing the benchmark set by experts from the International Bladder Cancer Group [2].

The approval of ANKTIVA in the UK is a significant step for ImmunityBio and could potentially expand its market reach, especially in the context of the growing demand for innovative cancer therapies. As the company continues to submit regulatory applications to the EMA, investors should closely monitor the progress of ANKTIVA’s expansion into the European market.

References:
[1] https://www.nasdaq.com/articles/immunitybios-anktiva-gains-uk-approval-bladder-cancer-treatment
[2] https://www.marketscreener.com/quote/stock/IMMUNITYBIO-INC-23160241/news/UK-MHRA-Approves-ImmunityBio-s-ANKTIVA-Plus-BCG-for-BCG-Unresponsive-Non-Muscle-Invasive-Bladder-50452104/