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The expanded indication covers ANKTIVA with BCG for adults with BCG-unresponsive non-muscle-invasive bladder cancer and papillary-only tumors. The FDA decision builds on the drug’s April 2024 approval for patients with carcinoma in situ, with or without papillary tumors.
ImmunityBio said the FDA expanded ANKTIVA’s indication to include BCG-unresponsive non-muscle invasive bladder cancer patients with papillary-only tumors.
For best results when printing this announcement, please click on link below: FDA Expands ANKTIVA(® )Approval for BCG-Unresponsive Non-Muscle-Invasive Bladder Cancer to Cover Both Papillary and CIS Disease Expanded indication extends ANKTIVA plus BCG to patients with BCG-unresponsive non-muscle-invasive bladder cancer