FDA accepts ImmunityBio’s BLA resubmission as complete, sets new PDUFA date

ImmunityBio announced that the U.S. Food and Drug Administration FDA has accepted for review ImmunityBio’s resubmission of its Biologics License Application or BLA for N-803, a first-in-class IL-15 superagonist, plus Bacillus Calmette-Guerin, BCG, for the treatment of BCG-unresponsive non-muscle-invasive bladder cancer carcinoma in situ CIS with or without Ta or T1 disease, and considered it as a complete response to the FDA’s May 9, 2023 complete response letter. The FDA has set a user fee goal date PDUFA date of April 23, 2024. “We are pleased that the FDA has accepted ImmunityBio’s resubmission of the BLA as a complete response, following our productive interactions leading up to the resubmission. We look forward to working closely with the Agency to finalize the review and to bringing this important immune-enhancing therapeutic to patients suffering from bladder cancer,” said Patrick Soon-Shiong, M.D., Executive Chairman and Global Chief Scientific and Medical Officer at ImmunityBio. ImmunityBio’s IL-15 superagonist N-803, also called Anktiva and nogapendekin alfa inbakicept.N-803 is currently being evaluated in adult patients in two clinical NMIBC trials. QUILT-2.005 is investigating use of N-803 in combination with BCG for patients with BCG-naive NMIBC; QUILT-3.032 is studying N-803 in combination with BCG in patients with BCG-unresponsive NMIBC CIS and Papillary Disease. N-803 is investigational. Safety and efficacy have not been established by any Health Authority or Agency, including the FDA.