ImmunityBio receives RTF letter from FDA for sBLA for use of ANKTIVA plus BCG

ImmunityBio (IBRX) announced that the company received a Refusal to File letter from the U.S. FDA for the supplemental biologics license application for use of ANKTIVA plus Bacillus Calmette-Guerin in BCG-unresponsive non-muscle invasive bladder cancer for the indication of papillary disease. This RTF letter was received despite reaching unanimous guidance and encouragement at the in-person January 2025 meeting from the leadership of the Agency, including from CBER, CDER and OCE to submit this sBLA. At this meeting all key decision makers were specifically asked and unanimously confirmed that ImmunityBio should submit the sBLA as soon as possible based on the data in the single-arm trial. Relying on this unanimous guidance the company submitted the sBLA in March 2025. The company has already requested an urgent meeting to resolve the inconsistencies between the directives provided at the January Meeting and receipt of the RTF letter.