FDA expands ANKTIVA approval to papillary-only bladder cancer after BCG failure
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.