ImmunityBio Inc (NASDAQ: IBRX) announced on Monday that the European Medicines Agency (EMA) has accepted its marketing authorisation application for ANKTIVA (nogapendekin alfa inbakicept-pmln) in combination with Bacillus Calmette-Guérin (BCG) for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) carcinoma in situ (CIS), with or without papillary tumors. The application spans 30 countries in the European Union, Iceland, Norway and Liechtenstein.

The submission is based on data from the ongoing QUILT 3.032 study, where 100 patients achieved a 71% complete response rate, with some responses lasting beyond 54 months--exceeding the 18-month benchmark suggested by the International Bladder Cancer Group. ANKTIVA, a first-in-class IL-15 agonist IgG1 fusion complex, activates natural killer cells and memory T cells, providing durable responses and immunogenic cell death.

ANKTIVA was FDA-approved in 2024 for BCG-unresponsive NMIBC CIS, marking it as the first FDA-approved immunotherapy targeting this condition.

ImmunityBio develops next-generation immunotherapies and vaccines aimed at enhancing the immune system to combat cancers and infectious diseases.