Home / Health / Macau Approves New Bladder Cancer Therapy
Macau Approves New Bladder Cancer Therapy
23 Mar
Summary
- Anktiva, a novel immunotherapy, received approval in Macau.
- The therapy targets BCG-unresponsive bladder cancer with CIS.
- The drug achieved a 71% complete response rate in studies.
ImmunityBio's Anktiva has secured its first approval in Asia, receiving authorization from the Macau Special Administrative Region's Pharmaceutical Administration Bureau. This approval is for Anktiva, in combination with Bacillus Calmette-Guérin (BCG), to treat adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) who have carcinoma in situ (CIS).
The therapy is a first-in-class interleukin-15 receptor agonist, designed to activate natural killer cells and CD8+ T cells. Clinical data from the QUILT-3.032 study showed Anktiva plus BCG achieved a 71% complete response rate in the target patient group, with a median response duration of 26.6 months.
This regulatory milestone in Macau was based on previous decisions from the US FDA and European Medicines Agency, aligning with local requirements. ImmunityBio is continuing discussions with other health authorities across Asia as part of its international regulatory strategy, aiming to provide global access to this immunotherapy.
