FDA approves an expanded indication for nogapendekin alfa inbakicept-pmln for BCG-unresponsive non-muscle invasive bladder cancer

FDA expanded Anktiva with BCG to include adults with BCG-unresponsive, high-grade papillary-only non-muscle invasive bladder cancer. FDA concluded that efficacy evidence from patients with carcinoma in situ could apply to this group because of overlapping clinical and non-clinical features.

Why it matters: FDA says it is finalizing guidance to address using carcinoma in situ study evidence to support approvals in high-grade papillary-only disease.