FDA Reviews Expanded ANKTIVA+BCG Indication for Papillary NMIBC; PDUFA Set for January 2027

ImmunityBio disclosed that the FDA has accepted for review a supplemental Biologics License Application to expand ANKTIVA when combined with BCG to treat BCG-unresponsive non-muscle invasive bladder cancer with papillary disease (no CIS). The FDA assigned a PDUFA target date of January 6, 2027. The submission relies on QUILT-3.032 Cohort B data and literature suggesting papillary NMIBC shares a biological profile with CIS, potentially allowing extrapolation from CIS trials. If approved, the expansion would broaden ANKTIVA+BCG to papillary-only NMIBC, offering a bladder-sparing, immunotherapy option and potentially delaying cystectomy, with safety data consistent with BCG alone and support from NCCN Category 2A guidance.