Posted by Michael Wonder on 20 May 2026
ImmunityBio announces FDA acceptance of supplemental BLA for Anktiva plus BCG in BCG-unresponsive non-muscle invasive bladder cancer with papillary disease
19 May 2026 - ImmunityBio today announced that the US FDA has accepted for review the supplemental biologics license application for Ankitiva (nogapendekin alfa inbakicept-pmln) in combination with Bacillus Calmette-Guerin (BCG) for the treatment of patients with BCG unresponsive non-muscle invasive bladder cancer with papillary disease without carcinoma in situ.
The FDA assigned a PDUFA target action date of 6 January 2027.
