Posted by Michael Wonder on 10 Mar 2026
ImmunityBio announces resubmission of supplemental BLA to the FDA for Anktiva plus BCG in BCG unresponsive NMIBC with papillary disease following agency review of additional data
9 March 2026 - ImmunityBio today announced that the US FDA has acknowledged receipt of its supplemental biologics license application for Anktiva (nogapendekin alfa inbakicept-pmln) plus Bacillus Calmette-Guérin (BCG) in BCG-unresponsive non-muscle invasive bladder cancer with papillary tumours.
The resubmission follows on-going discussions with the FDA beginning in January 2026, during which the Agency requested additional data to support its review.
