FDA expands ANKTIVA plus BCG label to papillary-only BCG-unresponsive NMIBC, widening IBRX market

ImmunityBio, Inc.

FDA expanded ANKTIVA (nogapendekin alfa inbakicept-pmln) plus BCG to treat BCG-unresponsive NMIBC with papillary-only tumors; first approval for this population.
Papillary disease is ~85% of NMIBC patients; NMIBC is ~80% of US bladder cancer diagnoses, materially expanding IBRX's US addressable population.
QUILT-3.032 Cohort A: 62% of 77 patients achieved complete response (95% CI 51-73); 58% maintained response >=12 months, 40% >=24 months.
Builds on April 2024 approval covering CIS with or without papillary tumors; label now covers all BCG-unresponsive NMIBC patients.
Most common TRAEs were instillation-related (dysuria, pollakiuria, hematuria), mostly grade 1-2; label warns delaying cystectomy can risk metastatic disease.

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