Long-term findings from the 100-patient QUILT-3.032 cohort show a 71% complete response rate with ANKTIVA plus BCG and 84.2% cystectomy-free survival at three years among responders. The findings strengthen evidence for sustained bladder preservation, although the study was nonrandomized and the preservation estimate does not apply to all treated patients.
The FDA has expanded ANKTIVA plus BCG to adults with BCG-unresponsive high-grade papillary-only non-muscle-invasive bladder cancer. The decision relies on existing clinical evidence and biological similarities with carcinoma in situ, rather than a new pivotal efficacy result specifically demonstrating treatment benefit in papillary-only patients.
ImmunityBio's first Asia approval for ANKTIVA in BCG-unresponsive bladder cancer: what the Macau clearance means for its global strategy. Read the analysis.
ImmunityBio has resubmitted its supplemental biologics license application to the U.S. Food and Drug Administration for ANKTIVA (nogapendekin alfa inbakicept) in combination with Bacillus Calmette-Guerin for BCG-unresponsive non-muscle invasive bladder cancer with papillary tumors, after the agency requested updated long-term efficacy data in March 2026. The resubmission follows a regulatory exchange that began in January
ImmunityBio expands ANKTIVA into Europe with Accord Healthcare. Discover what this means for bladder cancer care, regulation, and real-world adoption.
New Phase 2 data suggest ImmunityBio’s ANKTIVA plus CAR-NK combo could restore immune competence in glioblastoma. Find out why it matters.
Find out how ImmunityBio’s subcutaneous immunotherapy ANKTIVA secured Saudi approval for NSCLC and what it means for global immuno-oncology.
ImmunityBio Inc. has received a positive recommendation from the European Medicines Agency for conditional marketing authorization of its immunotherapy ANKTIVA (nogapendekin alfa inbakicept) in combination with Bacillus Calmette-Guérin for the treatment of BCG-unresponsive non-muscle invasive bladder cancer carcinoma in situ. The recommendation positions ANKTIVA as the first immunotherapy in the European Union for this indication,