Other Events ·
FDA expands ANKTIVA approval to include BCG-unresponsive NMIBC with papillary-only tumors
IBRXImmunityBio, Inc.
The U.S. Food and Drug Administration has expanded the approved indication for ANKTIVA (nogapendekin alfa inbakicept-pmln) in combination with Bacillus Calmette-Guérin (BCG) to include patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) presenting with papillary-only tumors. This approval broadens the therapy's eligibility beyond the April 2024 indication for carcinoma in situ (CIS), covering approximately 85% of the NMIBC patient population. The expansion is based on data from the QUILT-3.032 trial, where 62% of patients achieved a complete response. ImmunityBio operates as a biotechnology company focused on developing and commercializing next-generation immunotherapies.