Nogapendekin alfa inbakicept-pmln is an intravesical IL-15 receptor agonist immunotherapy marketed as ANKTIVA and used with BCG for selected non-muscle invasive bladder cancer patients. FDA approved this regimen in April 2024 for adults with BCG-unresponsive carcinoma in situ with or without papillary tumors. It is administered as induction and maintenance intravesical therapy in combination with BCG.
ImmunityBio resubmitted its supplemental BLA to the FDA for ANKTIVA in papillary bladder cancer after providing additional data. The company also received encouragement from Saudi regulators to submit a recombinant BCG application and expand ANKTIVA approvals.
ImmunityBio completed enrollment of 366 patients in its Phase 2 trial of ANKTIVA plus BCG versus BCG alone for BCG-naïve bladder cancer. Interim analysis showed statistically significant improvement in duration of complete response, with the company anticipating a BLA submission by Q4 2026.
