ImmunityBio, Inc.
FDA Refuses to File sBLA for Bladder Cancer Indication
Summary
On May 5, 2025, ImmunityBio, Inc. announced that the U.S. Food and Drug Administration (FDA) issued a Refusal to File (RTF) letter regarding the Company's supplemental biologics license application (sBLA) for the use of ANKTIVA plus BCG in BCG-unresponsive non-muscle invasive bladder cancer in the papillary indication. Despite previous encouragement from the FDA to submit the sBLA, the Company now faces an RTF letter for this indication, which contrasts with the FDA approval of the product for BCG-unresponsive NMIBC with Papillary tumors with CIS. ImmunityBio has requested an urgent meeting with the FDA to address this inconsistency. A copy of the press release is furnished as Exhibit 99.1 hereto.
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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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