FDA expands Anktiva approval to papillary-only BCG-unresponsive bladder cancer

FDA approval · BioPharm International · 2026-10-15. Number 1 in the UrologyWatch Top 5 for October 16, 2026.

FDA broadened the approval of nogapendekin alfa inbakicept (Anktiva, N-803) to include patients with papillary-only BCG-unresponsive non-muscle invasive bladder cancer, expanding its prior approval for CIS.

Why it matters: Gives clinicians an added intravesical option for BCG-unresponsive papillary disease, an area with limited bladder-sparing alternatives.

Source: BioPharm International

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