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# New Bladder Cancer Therapy Approved
- URL: https://www.fdaweb.com/new-bladder-cancer-therapy-approved/
- Published: 2024-04-23T12:00:00.000Z
- Updated: 2026-09-14T14:28:57.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156831

FDA has approved an ImmunityBio BLA for Anktiva (nogapendekin alfa inbakicept-pmln) plus Bacillus Calmette-Guérin (BCG) for treating patients with BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ, with or without papillary tumors. The therapy stimulates memory T cells, “leading to long duration of complete response exceeding 47 months and ongoing to date, with a median duration of response yet to be determined,” the company says.

“Anktiva not only proliferates and activates the patient’s own NK cells and CD8+ killer T cells, but also activates CD4+ T helper cells, thus enhancing the proliferation of memory killer T cells,” ImmunityBio says. “This novel mechanism of action, which mimics the biology of the dendritic cell, begins the evolution of immunotherapy beyond T cells alone. The combination of the proliferation of key cancer-killing immune cells, together with the activation of T cells with memory, results in durable complete responses.”

Approval was based on data from 77 patients in a single-arm study who received the therapy for up to 37 months. The complete response rate was 62% with the upper end of the confidence interval being 73%, ImmunityBio says. “The duration of complete response as of the November 2023 cut-off was more than 47 months and is ongoing to date.”

The company says the therapy is currently being studied in non-small-cell lung cancer, colorectal cancer, non-Hodgkin’s lymphoma, glioblastoma, solid tumors, and HIV. Future studies are planned for platinum-resistant ovarian cancer and acute myeloid leukemia.