23 May 2022 - Results for this FDA designated breakthrough therapy exceed historical complete response rates and duration of response of current approved therapies for this indication.
ImmunityBio today announced it has submitted a biologics license application to the U.S. FDA for N-803, a first-in-class IL-15 superagonist, plus Bacillus Calmette-Guérin (BCG) for the treatment of BCG unresponsive non-muscle invasive bladder cancer carcinoma in situ with or without Ta or T1 disease.