ImmunityBio's Supplemental BLA for ANKTIVA Plus BCG in Bladder Cancer Accepted by FDA
ImmunityBio, Inc. has announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental Biologics License Application (sBLA) for ANKTIVA in combination with Bacillus Calmette-Guerin (BCG) for treating patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with papillary disease. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of January 6, 2027. This acceptance follows a public workshop by the FDA, where experts discussed the biological similarities between carcinoma in situ (CIS) and papillary disease, supporting the potential expansion of ANKTIVA's indication. The sBLA is backed by data from the QUILT 3.032 Phase 2/3 trial, which showed promising results in disease-free survival and bladder preservation. 
