> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Expands Indication for Anktiva in Bladder Cancer
- URL: https://www.fdaweb.com/fda-expands-indication-for-anktiva-in-bladder-cancer/
- Published: 2026-10-14T16:29:25.000Z
- Updated: 2026-10-14T16:29:25.000Z
- Author: David McFarland
- Tags: Biologics

FDA has approved Altor BioScience’s Anktiva (nogapendekin alfa inbakicept-pmln) with Bacillus Calmette-Guérin (BCG) for adults with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). The approval revises the prior indication for adults with BCG-unresponsive NMIBC with carcinoma in situ (CIS) with or without papillary tumors to include patients with high-grade papillary-only tumors, according to an [agency release](https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-expanded-indication-nogapendekin-alfa-inbakicept-pmln-bcg-unresponsive-non-muscle?ref=fdaweb.com).

“The current approval expands the indication to include patients with BCG-unresponsive high-grade NMIBC with papillary-only tumors based on review of available scientific information,” the agency says. “While high-grade papillary and CIS tumors have different architectural growth features, both are considered aggressive urothelial carcinomas, frequently coexist, can be difficult to distinguish pathologically, and, in the BCG-unresponsive setting, are associated with high risk for tumor recurrence and progression. Based on the overlapping clinical and non-clinical features of these two histologic types, the FDA concluded that the prior demonstration of efficacy in patients with BCG-unresponsive NMIBC containing CIS could be extrapolated to patients with BCG-unresponsive high-grade papillary disease.”

Additionally, FDA noted that it is working to finalize it guidance “Bacillus Calmette-Guérin-Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drugs and Biological Products for Treatment”' to address the approach on which this approval relied.