ImmunityBio, Inc. announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for ANKTIVA^® (nogapendekin alfa inbakicept-pmln) in combination with Bacillus Calmette-Guérin (BCG) for the treatment of certain bladder cancer patients. This is the first marketing approval outside the U.S. for this novel lymphocyte-stimulating agent.

“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,” said Dr. Patrick Soon-Shiong, Founder, Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio. “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.”

“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.

ANKTIVA is a first-in-class IL-15 agonist that activates and proliferates natural killer (NK) cells and CD4+ and CD8+ T cells. It is designed to restore immune competence by reversing lymphopenia—a condition in which cancer and conventional therapies, such as chemotherapy, radiation and checkpoint inhibitors, reduce the number and function of immune cells. Restoring immune function is essential for immunosurveillance, immunogenic cell death, and sustained tumor control. The BioShield platform’s effectiveness can be monitored using a routine complete blood count (CBC).

ANKTIVA was designated a Breakthrough Therapy by the FDA and received approval from both the FDA and MHRA based on its safety and efficacy outcomes of complete response (CR) and duration of response (DOR). In a single-arm, multicenter trial, 77 evaluable patients received ANKTIVA with BCG for up to 37 months.

As of the November 2023 data cutoff, the duration of complete response for some patients exceeded 47 months and remains ongoing. These extended duration of complete responses beyond 24 months with ANKTIVA and BCG surpasses the benchmark for meaningful clinical results set by experts from the International Bladder Cancer Group.

ImmunityBio has also submitted regulatory applications to the European Medicines Agency (EMA) to expand availability of ANKTIVA across the 27 European Union (EU) member states, as well as Iceland, Norway and Liechtenstein.