FDA expands Anktiva approval to include papillary-only bladder cancer

The FDA approved an expanded indication for nogapendekin alfa inbakicept-pmln (Anktiva) with Bacillus Calmette-Guérin (BCG) for adults with BCG-unresponsive non-muscle-invasive bladder cancer. The revised indication includes high-grade papillary-only tumors, in addition to tumors with carcinoma in situ, with or without papillary tumors.

The FDA based the expansion on its review of available scientific information, saying the two tumor types share clinical and non-clinical features and that efficacy findings in patients with carcinoma in situ could be extrapolated to patients with papillary-only disease. In the earlier trial cohort of 77 patients with carcinoma in situ, with or without papillary disease, the complete response rate was 62% (95% CI: 51, 73). The FDA warned that delaying cystectomy can lead to metastatic bladder cancer, which can be lethal.