FDA Widens Anktiva Use to Papillary Tumors in 85% of Bladder Cancer Cases

The U.S. Food and Drug Administration cleared ImmunityBio Inc.'s Anktiva for a more common form of non-muscle invasive bladder cancer on Oct. 14, months ahead of the Jan. 6, 2027 decision deadline the agency had set last May.

Anktiva now covers papillary tumors, finger-like growths off the bladder lining that ImmunityBio says show up in about 85% of non-muscle invasive bladder cancer patients. The agency's first approval, in April 2024, reached only patients with visible cancer cells who had not responded to Bacillus Calmette-Guérin treatment, and Anktiva is given alongside BCG. ImmunityBio, based in Culver City, was founded more than a decade ago by Patrick Soon-Shiong; Anktiva was its first marketable drug.

The FDA rejected an earlier request for the broader indication in early 2025 and asked for more supporting data. ImmunityBio filed that data, and the agency then scheduled a January 2027 review. The ruling instead arrived Oct. 14, announced by the company and the FDA.

Shares rose 4% on the announcement, closing Oct. 14 at $9.91. The stock has since surrendered that increase and traded at its lowest level since Sept. 28.