FDA Expands Approval for ImmunityBio Bladder Cancer Treatment ANKTIVA

ImmunityBio, Inc. (NASDAQ:IBRX) received expanded approval from the U.S. Food and Drug Administration for its immunotherapy drug ANKTIVA, used in combination with Bacillus Calmette-Guérin. The expanded label allows the treatment to be used for adult patients with BCG-unresponsive non-muscle-invasive bladder cancer who have papillary-only tumors. This marks the first FDA approval for this specific patient population.

The decision expands upon an April 2024 approval that covered patients with carcinoma in situ disease. Non-muscle-invasive bladder cancer represents about 80% of all U.S. bladder cancer diagnoses, and an estimated 85% to 90% of these patients present with papillary disease. Patients with high-grade papillary tumors that stop responding to standard treatments historically faced high rates of recurrence and progression with few nonsurgical options. The expanded approval significantly increases the addressable patient base for ANKTIVA.

Investors will monitor ImmunityBio's commercial rollout and adoption rates among urology practices as the company expands access to the newly eligible patient group. Market participants will also track sales growth following the label expansion, as well as any further clinical updates regarding long-term treatment responses and safety monitoring.