FDA Expands ANKTIVA® Approval for BCG-Unresponsive Non-Muscle-Invasive Bladder Cancer to Cover Both Papillary and CIS Disease
ImmunityBio won an expanded FDA label for ANKTIVA plus BCG, covering all patients with BCG-unresponsive non-muscle-invasive bladder cancer including papillary-only tumors. This is the first FDA approval for papillary-only BCG-unresponsive NMIBC, a segment representing roughly 85% of the NMIBC population, dramatically enlarging ANKTIVA's addressable market.
Key figures
- Drug Name
- ANKTIVA (nogapendekin alfa inbakicept-pmln)
- Phase Of Trial
- QUILT-3.032 trial
- Papillary share of nmibc
- approximately 85%
- Responders maintained 12mo
- 58%
- Responders maintained 24mo
- 40%
- Quilt 3032 complete response
- 62% of 77 patients (95% CI: 51, 73)
AI analysis
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