FDA Broadens Approval for Bladder Cancer Therapy Anktiva

The U.S. Food and Drug Administration (FDA) has expanded the approval of Anktiva (nogapendekin alfa inbakicept-pmln), used with BCG, for adults with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). This expanded indication now includes patients with high-grade papillary-only tumors, offering new treatment options for this aggressive form of bladder cancer. It marks the first FDA-approved treatment specifically for BCG-unresponsive, high-grade papillary-only disease.