A New Approved Use

The FDA says Anktiva is the first approved treatment specifically for certain adults with BCG-unresponsive, high-grade papillary-only bladder cancer.

Who It Covers

For this indication, cancer has not grown into the bladder muscle; it applies to adults with a specific non-muscle-invasive disease.

Papillary tumors grow from the bladder lining as small, finger-like projections, without carcinoma in situ, or CIS.

Anktiva, also called nogapendekin alfa inbakicept-pmln, is delivered with BCG directly into the bladder, not instead of it.

The FDA considered earlier CIS trial results alongside clinical and laboratory evidence of similarities with high-grade papillary tumors.

In an earlier CIS study, 62% achieved complete response; these results were not measured specifically in the newly approved papillary-only group.

The prescribing information warns that delaying bladder-removal surgery can allow cancer to spread elsewhere in the body and become fatal.