ImmunityBio, Inc.
ImmunityBio Receives European Commission Authorization for ANKTIVA with BCG
Summary
On February 18, 2026, ImmunityBio, Inc. announced that the European Commission has granted conditional marketing authorization for ANKTIVA in combination with Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) carcinoma in situ (CIS). This authorization marks a significant milestone as ANKTIVA becomes the first immunotherapy to receive marketing authorization in Europe for NMIBC CIS, with or without papillary tumors, where no treatment was previously authorized for BCG-unresponsive disease. The conditional marketing authorization enables commercial availability across all 27 European Union member states plus Iceland, Liechtenstein, and Norway, expanding ANKTIVA's global footprint to 33 countries. The decision addresses a significant unmet medical need in Europe, where over 150,000 patients are diagnosed annually with NMIBC, and the primary alternative for BCG-unresponsive patients was radical cystectomy. The authorization is based on the positive opinion adopted by the European Medicines Agency’s Committee for Medicinal Products for Human Use, recommending authorization due to the demonstrated benefits of ANKTIVA, which achieved a complete response rate of 71%.
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About ImmunityBio, Inc.
ImmunityBio, Inc. is a pioneering biotechnology company that focuses on developing innovative immunotherapies to treat cancer and other serious diseases. The company's primary function is to leverage the body's immune system to fight against various forms of cancer as well as infectious diseases through a robust pipeline of therapies. ImmunityBio's notable features include its expansive portfolio of next-generation therapies that incorporate cutting-edge technologies, such as the NANT Cancer Vaccine and Anktiva, which are designed to enhance the immune system's natural ability to identify and eradicate tumor cells. The company plays a critical role in the healthcare and biotechnology sectors, contributing to advancements in personalized medicine and potentially transformative treatments. Headquartered in California, ImmunityBio is strategically placed in the biotechnology hub of the United States, allowing it to effectively collaborate with key players in research and clinical development. Its work is significant in the market as it represents the ongoing shift towards immunotherapy as a front-line treatment for cancer, promising to impact patient outcomes and the future of cancer care.
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