This regulatory update builds upon the agency’s April 2024 approval, which initially cleared Anktiva for use alongside Bacillus Calmette-Guérin in patients with carcinoma in situ. By including those with papillary-only tumors, the FDA aims to provide a more robust defense against aggressive forms of the disease that carry a high risk of progression and recurrence.

The agency based its decision on a comprehensive review of existing clinical data and prior trial results. For patients whose cancer resists primary immunotherapy, this expansion offers a critical secondary pathway to manage the malignancy before it advances further.