ImmunityBio, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental Biologics License Application (sBLA) for Anktiva® (nogapendekin alfa inbakicept) in combination with BCG for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with papillary disease.
ImmunityBio, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental Biologics License Application (sBLA) for Anktiva® (nogapendekin alfa inbakicept) in combination with BCG for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with papillary disease.
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The FDA has also set the Prescription Drug User Fee Act (PDUFA) target date for this application—January 6, 2027. This sBLA submission is based on positive data from a pivotal phase 2/3 clinical trial. The study evaluated the efficacy and safety of Anktiva in combination with BCG in BCG-unresponsive NMIBC patients. Data show that this combination therapy significantly improved the complete response rate and demonstrated good tolerability. If approved, Anktiva combined with BCG will provide an important new treatment option for this patient population with limited therapeutic choices. The PDUFA date marks the FDA’s target timeline for completing its review, but the final decision may come before or after this date.
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