IBRX ImmunityBio

ImmunityBio Reports Long-Term Phase 2/3 QUILT-3.032 Data for ANKTIVA + BCG in BCG-Unresponsive NMIBC

Peer-reviewed Journal of Urology publication of long-term follow-up from the QUILT-3.032 study shows 71% CR rate, median CR duration of 26.6 months (extending beyond 53 months), 84% cystectomy-free survival at 36 months, and 98.2% disease-specific survival at 3 years in BCG-unresponsive NMIBC with CIS. No Grade 4/5 TRAEs reported. This adds durability data to the already FDA-approved therapy.

ImmunityBio Anktiva receives FDA expanded approval in BCG-unresponsive NMIBC

The FDA approved an expanded indication for nogapendekin alfa inbakicept-pmln (Anktiva) in combination with BCG for adults with BCG-unresponsive non-muscle invasive bladder cancer. This expands the prior label for the ImmunityBio asset.

ImmunityBio ANKTIVA Label Expanded to Include BCG-Unresponsive NMIBC with Papillary-Only Tumors

The FDA expanded the label for ANKTIVA (nogapendekin alfa inbakicept-pmln) plus BCG to treat adult patients with BCG-unresponsive NMIBC, now explicitly covering both papillary-only disease and CIS (with or without papillary tumors). This builds on the April 2024 approval limited to CIS-containing disease and is the first approval for papillary-only BCG-unresponsive NMIBC, increasing the addressable patient population (papillary disease ~85% of NMIBC). The expansion was based on prior QUILT-3.032 efficacy data without new trials.

ANKTIVA · NCT07123727 registry update

primary_completion: 2026-07 → 2027-03; completion: 2026-07 → 2027-03

ImmunityBio: FDA sets Jan 6 2027 PDUFA for ANKTIVA sBLA in papillary NMIBC

The FDA accepted the sBLA for ANKTIVA plus BCG in BCG-unresponsive NMIBC papillary disease without CIS. A PDUFA target action date of January 6, 2027 was assigned, establishing a formal regulatory review timeline for this new indication.

ImmunityBio to present Japan BCG Laboratory Tokyo strain agreement at AUA 2026

ImmunityBio signed an exclusive U.S. Development and Supply Agreement with Japan BCG Laboratory for the Tokyo strain of BCG. The company will be sole BLA applicant for this second potential BCG source to address U.S. supply needs. Details will be presented at the AUA Annual Meeting on May 16, 2026.