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.
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.
Bladder-sparing therapy needs better sequencing. Ferring’s ADSTILADRIN re-induction signal raises hope, but durability is the real test.
ImmunityBio expands ANKTIVA into Europe with Accord Healthcare. Discover what this means for bladder cancer care, regulation, and real-world adoption.