ImmunityBio wins expanded Anktiva approval after quarterly revenue of $50.7 million
Key Facts
The U.S. Food and Drug Administration on October 14, 2026, expanded approval of ImmunityBio's Anktiva to include a new group of adults with non-muscle-invasive bladder cancer. The decision covers patients with BCG-unresponsive high-grade papillary-only tumors, according to the agency's announcement. The agency said the drug became its first approved treatment specifically for this patient group. The original U.S. approval, issued in April 2024, covered BCG-unresponsive disease with carcinoma in situ, with or without papillary tumors. The decision thus adds papillary-only disease to the approved indication, subject to conditions concerning tumor grade and lack of response to prior treatment.
The agency based the expanded approval on extrapolating the treatment's established efficacy in patients with carcinoma in situ to high-grade papillary disease. It said shared characteristics between the two forms of the disease allowed it to use this approach in assessing the application for an expanded indication. The study supporting the original approval recorded a complete response rate of 62% in patients with carcinoma in situ, according to the agency. Anktiva targets the antitumor immune response, with ImmunityBio saying it activates natural killer cells. The company added that it restores memory T-cell activity as part of its mechanism for combating tumors that evade T cells.
In the papillary-only patient group, ImmunityBio reported disease-free survival of 58.2% at 12 months. Progression-free survival was 94.9% at the same follow-up point, according to results the company announced for this group. At 36 months, progression-free survival was 82.0%, according to longer-term follow-up results for the papillary cohort. Cystectomy-free survival was also 92.2% at 12 months, another measure the company reported in its clinical results. Cystectomy-free survival was 83.1% at 36 months, according to its statement presenting bladder-preservation outcomes during follow-up.
Anktiva is administered by intravesical instillation, according to drug-use information published by the company. The FDA sets the recommended induction dose at 400 micrograms of the drug in combination with BCG. The combination is administered once a week for 6 weeks during induction, according to the agency's instructions for the expanded approval. The drug's prescribing information includes a warning about delaying cystectomy in patients receiving treatment. The agency warns that "delaying cystectomy may lead to metastatic bladder cancer," a warning included in the drug's prescribing information.
The U.S. expansion comes after ImmunityBio reported net product revenue of $50.7 million in the second quarter of 2026, up 92% year on year. Net product revenue in the first half of the year reached $94.8 million, up 121% from the same period a year earlier, according to the company's financial announcement. The company estimates that papillary disease accounts for about 85% of all patients with non-muscle-invasive bladder cancer, while the new approval applies to BCG-unresponsive high-grade disease. Regionally, approval in the United Arab Emirates preceded the U.S. decision in covering papillary-only disease, according to ImmunityBio's statement. Eligible groups under the UAE approval included patients with carcinoma in situ alone or with papillary tumors, as well as papillary tumors without carcinoma in situ.
The expanded approval followed a regulatory setback, with ImmunityBio saying the agency sent a refusal-to-file letter for the expansion application on May 2, 2025. The previously targeted decision date for the application was January 6, 2027, before approval came earlier. The agency is currently finalizing guidance on developing treatments for this disease to address the extrapolation approach used in expanding the approval. R. Angelo de Claro, director of the agency's Oncology Center of Excellence, said "this approach may also help guide the development of future treatments." Finalizing that guidance places the regulatory approach used for Anktiva within the agency's forthcoming work on developing treatments for non-muscle-invasive bladder cancer.