The FDA added high-grade papillary-only bladder cancer to Anktiva’s approved use, giving ImmunityBio access to more potential patients. The decision relies on results from CIS patients, not a separate papillary-only trial, but the FDA said those results apply to both.
The wider approval gives ImmunityBio a larger group of patients who may receive Anktiva, which could support future sales. The supporting trial studied patients with CIS, not a separate group with papillary-only disease. The FDA said the trial results apply to both groups.
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