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UK MHRA Approves ImmunityBio’s ANKTIVA® Plus BCG for BCG-Unresponsive Non-Muscle Invasive Bladder Cancer Carcinoma In Situ
ANKTIVA, a first-in-class, lymphocyte-stimulating agent, works synergistically with BCG to activate and proliferate natural killer (NK) and T cells, helping
About this update from Immunitybio, Inc.
[{"type":"text","content":"\n\nANKTIVA, a first-in-class, lymphocyte-stimulating agent, works synergistically with BCG to activate and proliferate natural killer (NK) and T cells, helping eliminate cancer\n\n\n\nAlready approved in the U.S. and designated as a Breakthrough Therapy by the FDA, this marks ANKTIVA’s first marketing approval outside the U.S.\n\n\n\nANKTIVA plus BCG offers a new option for eligible patients among the 16,400 to 18,000 people diagnosed with NMIBC in the UK each year1\n\n\n\n CULVER CITY, Calif.--(BUSINESS WIRE)--\nImmunityBio, Inc. (NASDAQ: IBRX) today 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.\n\n\n“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.”\n\n\n“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.\n\n\nANKTIVA 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).\n\...