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Thomas Flaig, MD


FDA Accepts Biologics License Application for Immunotherapy Combination in Bladder Cancer

By: JNCCN 360 Staff
Posted: Thursday, August 4, 2022

The U.S. Food and Drug Administration (FDA) recently accepted the biologics license application for ImmunityBio’s N-803, an interleukin-15 superagonist, in combination with the bacillus Calmette-Guérin (BCG) vaccine in the treatment of patients with BCG-unresponsive non–muscle-invasive bladder cancer carcinoma in situ. The FDA has granted this antibody cytokine fusion protein combination therapy Breakthrough Therapy and Fast Track designations. If approved, N-803 plus the BCG vaccine would reportedly be the first immunotherapy combination for this indication in more than 20 years. N-803 is also being studied in advanced metastatic pancreatic cancer.

The application is based on results from a series of studies, including the ongoing phase II/III QUILT 3.032 trial. In this study, 71% of patients who had failed to respond to previous therapies had a more than 50% increase in both response and median duration compared with valrubicin and pembrolizumab.

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