Overview
- ImmunityBio said the FDA accepted its supplemental application to extend ANKTIVA’s use to patients with non‑muscle‑invasive bladder cancer who do not respond to BCG therapy.
- The agency set a target decision date of January 6, 2027 for the review.
- The filing cites the Phase 2/3 QUILT 3.032 study in 80 patients, which reported a 12‑month disease‑free survival rate of 58.2%.
- ImmunityBio shares traded up about 8% before the market opened to $8.39 after the news, according to Benzinga Pro.
- A day earlier, the company shared indirect comparisons suggesting stronger responses and fewer side effects versus rival intravesical therapies, though these were not head‑to‑head trials and overall survival differences were not significant.