FDA Expands Approval for Bladder Cancer Drug Anktiva
The regulatory agency authorized the use of ImmunityBio's drug for patients with papillary tumors.
Updated on Oct. 26, 2026 in Cancer
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The U.S. Food and Drug Administration approved the expanded use of the drug Anktiva to treat patients with non-muscle invasive bladder cancer involving papillary tumors. The treatment is designed to be used in conjunction with Bacillus Calmette-Guérin therapy.
Why it matters
This approval significantly broadens the potential patient population for the drug, as papillary tumors are present in roughly 85% of non-muscle invasive bladder cancer cases. The decision follows a previous rejection of the expanded use application in early 2025.
Papillary tumors affect approximately 85% of patients diagnosed with non-muscle invasive bladder cancer. Following the FDA announcement, shares of Culver City-based ImmunityBio closed at $9.91 on October 14, marking a 4% increase.
The players
U.S. Food and Drug Administration
This federal agency is responsible for protecting public health by ensuring the safety, efficacy, and security of human drugs and biological products.
ImmunityBio
Based in Culver City, this biotechnology company focuses on developing therapies for cancer and infectious diseases.
The details
ImmunityBio secured this approval after submitting additional clinical data to the FDA to address concerns that led to a rejection of their application in early 2025. The agency granted the authorization ahead of a previously scheduled January 6, 2027 decision deadline.
Timeline
April 2024: Anktiva receives initial FDA approval for a rare form of bladder cancer.
Early 2025: The FDA rejects the expanded use application for the drug.
October 14, 2026: The FDA grants approval for the expanded use of Anktiva.
Health Landscape
The expansion of Anktiva's label underscores the rigorous evaluation inherent in the FDA drug approval process. This decision marks a successful outcome for the company after it navigated a previous regulatory rejection through additional clinical data submissions.
Patients with papillary tumors may now access a new treatment option in combination with standard Bacillus Calmette-Guérin therapy. This change potentially shifts the standard of care for a significant majority of those currently managing non-muscle invasive bladder cancer.
The takeaway
Patients should consult with their oncologists to determine if this newly approved combination therapy is appropriate for their specific diagnosis. Healthcare providers can now offer an expanded range of therapeutic options for managing papillary tumors in bladder cancer.
Further reading
For more information on current treatment standards, visit the Cancer section.
Source note: This article includes information reported by Los Angeles Business Journal.
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