ImmunityBio Files BLA for Bladder Cancer Therapy

FDA has accepted for review an ImmunityBio BLA for its antibody cytokine fusion protein as a treatment for patients with Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer with or without Ta or T1 disease. The agency has set a 5/23/2023 user fee review action target date.

The submission is based on data from the QUILT 3.032 trial results in which 71% of BCG-unresponsive patients who had failed on previous therapies showed a complete response with a median duration of 26.6 months, the company says.

“N-803 has a unique mechanism of action that leads to the proliferation of NK and T cells that are cells of the adaptive and innate immune system,” ImmunityBio says. “Through this action, N-803 provides a secondary boost to the immunological response generated by BCG for bladder cancer, or by a checkpoint inhibitor for other indications.