FDA Expands ANKTIVA Approval for BCG-Unresponsive Bladder Cancer

The U.S. Food and Drug Administration expanded ANKTIVA’s use with Bacillus Calmette-Guérin (BCG) on Oct. 14 to cover adults with high-grade papillary-only bladder cancer that has not responded to BCG or spread into the bladder muscle.

The expanded indication covers a type of non-muscle invasive bladder cancer. ANKTIVA was previously approved for patients with carcinoma in situ, with or without papillary tumors. The expansion applies evidence from that earlier approval to high-grade papillary-only disease based on clinical and laboratory similarities between the cancers.

Evidence included Cohort A of the QUILT-3.032 trial, in which 62% of 77 patients achieved a complete response. Among those responders, 58% maintained the response for at least 12 months and 40% for at least 24 months. The trial included patients with carcinoma in situ, with or without papillary disease, so it did not measure a response rate specifically for papillary-only tumors.

ANKTIVA is administered with BCG directly into the bladder through a catheter. The recommended schedule begins with six weekly induction doses, followed by a 15-dose maintenance course.

The FDA described ANKTIVA as the first approved treatment specifically for BCG-unresponsive, high-grade papillary-only disease. Its prescribing information warns that delaying bladder-removal surgery can lead to metastatic bladder cancer, which can be lethal.