ImmunityBio resubmits FDA application for ANKTIVA in bladder cancer after agency requests updated efficacy data

ImmunityBio resubmits FDA application for ANKTIVA in bladder cancer after agency requests updated efficacy data

ImmunityBio has resubmitted its supplemental biologics license application to the U.S. Food and Drug Administration for ANKTIVA (nogapendekin alfa inbakicept) in combination with Bacillus Calmette-Guerin for BCG-unresponsive non-muscle invasive bladder cancer with papillary tumors, after the agency requested updated long-term efficacy data in March 2026. The resubmission follows a regulatory exchange that began in January […]

EMA backs ANKTIVA for bladder cancer: What it means for EU patients and future immunotherapies

EMA backs ANKTIVA for bladder cancer: What it means for EU patients and future immunotherapies

ImmunityBio Inc. has received a positive recommendation from the European Medicines Agency for conditional marketing authorization of its immunotherapy ANKTIVA (nogapendekin alfa inbakicept) in combination with Bacillus Calmette-Guérin for the treatment of BCG-unresponsive non-muscle invasive bladder cancer carcinoma in situ. The recommendation positions ANKTIVA as the first immunotherapy in the European Union for this indication, […]