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.

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