FDA Expands Indication for ImmunityBio's Bladder Cancer Drug
By Katherine Hamilton
The Food and Drug Administration has expanded its approved indication for ImmunityBio's Anktiva, a bladder-cancer treatment.
The new indication expands Anktiva to be used in combination with Bacillus Calmette-Guérin for patients with BCG-unresponsive non-muscle invasive bladder cancer with papillary-only tumors.
The broadened indication builds on the FDA's April 2024 approval of Anktiva plus BCG for patients with BCG-unresponsive bladder cancer with carcinoma in situ, with or without papillary tumors.
Carcinoma in situ and papillary tumors are aggressive and associated with high risk of recurrence and progression among patients who don't respond to BCG, an immunotherapy used to treat early stage bladder cancer.
The FDA expanded the indication based on a review of available information, including previously demonstrated efficacy data from prior trials.
Write to Katherine Hamilton at katherine.hamilton@wsj.com
(END) Dow Jones Newswires
October 14, 2026 16:59 ET (20:59 GMT)
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