Posted by Michael Wonder on 28 Jul 2022
ImmunityBio announces FDA acceptance of biologics license application for N-803 in BCG-unresponsive non-muscle invasive bladder cancer carcinoma in situ
28 July 2022 - This acceptance represents the first regulatory filing for N-803, an IL-15 superagonist, which was granted breakthrough therapy and fast track designations in combination with BCG from the U.S. FDA for this indication with a target PDUFA date of 23 May 2023.
The FDA accepted for review a biologics license application from ImmunityBio for its antibody cytokine fusion protein as a treatment for patients with BCG-unresponsive non-muscle-invasive bladder cancer carcinoma in situ with or without Ta or T1 disease.
