Posted by Michael Wonder on 04 Dec 2019
ImmunityBio granted FDA breakthrough therapy designation for N-803 IL-15 superagonist in non-muscle invasive bladder cancer
4 December 2019 - Results of Phase 1 and 2 studies in BCG unresponsive non-muscle invasive bladder cancer in high risk carcinoma in situ disease earn FDA breakthrough status for ImmunityBio’s IL-15 superagonist complex.
ImmunityBio has received breakthrough therapy designation from the U.S. FDA for its interleukin-15 (IL-15) agonist complex, N-803, in combination with Bacillus Calmette-Guerin (BCG), for the treatment of patients with BCG-unresponsive non-muscle invasive bladder carcinoma in situ.
This grant of breakthrough designation follows on the receipt of fast track designation from the U.S. FDA for N-803 in 2017.
