ImmunityBio (NASDAQ:IBRX) is moving toward a significant label expansion for its first-in-class immunotherapy, ANKTIVA® (nogapendekin alfa inbakicept), following a pivotal Type B meeting with the U.S. Food and Drug Administration (FDA).
The meeting focused on the regulatory path for treating BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with papillary tumors—a high-risk condition that currently lacks approved non-surgical therapies.
The FDA has provided a specific roadmap for a potential resubmission of the supplemental Biologics License Application (sBLA), which was initially filed in early 2025.
Crucially, the agency did not request any new clinical trials.
Instead, ImmunityBio will provide additional analyses of its existing five-year dataset within the next 30 days to address the FDA's queries.
The sBLA is backed by updated long-term results from the QUILT-3.032 trial (Cohort B), which focused on 80 patients with high-grade papillary-only disease.
The data, recently published in The Journal of Urology, represents some of the most durable outcomes in this patient population.
At 36 months, nearly all patients in the study survived their bladder cancer, with the median survival not yet reached even after five years.
Additionally, over 80% of patients successfully avoided radical cystectomy (surgical removal of the bladder) through three years of follow-up.
The study also met its primary endpoint with a significant 12-month DFS rate.
ANKTIVA is already approved in the U.S., UK, and EU for NMIBC with carcinoma in situ (CIS).
The company is aggressively pursuing global parity for the papillary-only indication.
Pending U.S. approval for the papillary-only label, ImmunityBio plans to immediately extend this indication to the European Medicines Agency (EMA) and other global authorities.