ImmunityBio has received approval from the Pharmaceutical Administration Bureau (ISAF) of the Macau Special Administrative Region, China, for Anktiva (nogapendekin alfa inbakicept-pmln) in combination with Bacillus Calmette-Guérin (BCG) for bladder cancer.
This approval covers adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) who have carcinoma in situ (CIS), with or without papillary tumours.
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The authorisation follows a review by ISAF that relied on prior regulatory decisions from the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), aligning with local requirements.
The regulatory milestone is ImmunityBio’s first authorisation for Anktiva in Asia. Across the region, the company continues to engage with other health authorities as part of its international regulatory strategy.
Anktiva is a first-in-class interleukin-15 receptor agonist designed to activate natural killer cells and cluster of differentiation 8 (CD8)+ T cells.
In the QUILT-3.032 study involving patients with BCG-unresponsive NMIBC CIS with or without papillary tumours, Anktiva plus BCG achieved a complete response rate of 71%, with 26.6 months median response duration.
ImmunityBio founder, executive chairman, and global chief scientific and medical officer Patrick Soon-Shiong said: “This approval in Macau reflects the strength of the clinical and regulatory foundation supporting Anktiva in BCG-unresponsive NMIBC CIS, with or without papillary tumours.
“The data from QUILT 3.032, published in NEJM Evidence and The Journal of Urology, demonstrate durable responses in this disease setting. As we continue to work with regulatory authorities, our focus remains on enabling global access to an immunotherapy designed to activate NK and T-cell function and address the underlying immune deficit in bladder cancer.”
In June 2025, the FDA granted expanded access authorisation for ImmunityBio’s Cancer BioShield platform, anchored by Anktiva, to treat lymphopenia in adults with refractory or relapsed solid tumours.
