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 gains UAE authorization for ANKTIVA in broader bladder cancer and metastatic lung cancer uses, widening its Gulf commercial opportunity.
Bladder cancer care is shifting from survival alone to treatment trade-offs. ImmunityBio’s NMIBC survey shows why preference now matters.
Bladder cancer drugs face a value test. ImmunityBio’s ANKTIVA analysis raises new questions on cost, response durability and access.
ANKTIVA already has an NMIBC foothold. The harder test is whether FDA reviewers accept extrapolation into papillary-only disease.
A bladder cancer supply crisis meets fresh Phase III data. ImmunityBio’s Tokyo BCG deal could test how flexible U.S. regulators are willing to be.
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.