FDA Broadens Anktiva Approval for Bladder Cancer Patients

The FDA has expanded the approved use of Anktiva (nogapendekin alfa inbakicept-pmln) in combination with BCG for adults with BCG-unresponsive non-muscle invasive bladder cancer. This expansion now includes patients with high-grade papillary-only tumors, marking the first FDA-approved treatment specifically for this patient group. The decision broadens the prior indication, offering a new therapeutic option for a specific subset of bladder cancer patients.