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.
Replicate Bioscience is extending its low-dose self-replicating RNA platform into tuberculosis, but immunological complexity, late-stage competition and global affordability create a demanding development path.
Imfinzi has FDA approval with BCG in early high-risk bladder cancer. The next test is adoption, recurrence data and real-world use.
Imfinzi moves into early bladder cancer, but can AstraZeneca turn a DFS win into real-world bladder-preserving impact?
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.
Forlong Biotechnology brings FL115 to ASCO 2026 with first-in-human solid tumor data. Read why the IL-15 story could matter beyond the poster.