Posted by Michael Wonder on 24 Oct 2023
ImmunityBio announces biological license application resubmission for N-803 in BCG unresponsive non-muscle invasive bladder cancer carcinoma in situ
23 October 2023 - Following the type A meeting with the FDA, ImmunityBio has completed the BLA resubmission addressing the issues in the complete response letter.
ImmunityBio today announced it has completed the resubmission of its biologics license application to the US FDA for N-803 (Anktiva), a first-in-class IL-15 superagonist, plus Bacillus Calmette-Guérin for the treatment of BCG unresponsive non-muscle invasive bladder cancer carcinoma in situ with or without Ta or T1 disease.
