ImmunityBio secures first Asian approval for Anktiva bladder cancer drug in Macau

CHINA—ImmunityBio has secured approval from Macau’s Pharmaceutical Administration Bureau (ISAF) for Anktiva (nogapendekin alfa inbakicept-pmln), marking the company’s first authorisation for the drug anywhere in Asia.

The approval covers the use of Anktiva in combination with Bacillus Calmette-Guérin (BCG) for adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) who have carcinoma in situ (CIS), with or without papillary tumours.

ISAF based its decision on prior regulatory approvals from both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), adapting those findings to meet local requirements.

What makes Anktiva different

Anktiva is a first-in-class interleukin-15 receptor agonist—a type of immunotherapy that works by activating natural killer (NK) cells and CD8+ T cells, which are key components of the body’s immune response against cancer.

The drug targets a specific immune deficit associated with bladder cancer, offering a mechanism distinct from conventional treatments.

Clinical evidence behind the drug

The approval draws on data from the QUILT-3.032 clinical study, which enrolled patients with BCG-unresponsive NMIBC CIS, with or without papillary tumours.

In that trial, Anktiva combined with BCG achieved a complete response rate of 71%, with a median response duration of 26.6 months.

Researchers published these findings in two leading medical journals—NEJM Evidence and The Journal of Urology—reinforcing the durability of the treatment outcomes observed.

Company’s global strategy

Patrick Soon-Shiong, ImmunityBio’s founder, executive chairman, and global chief scientific and medical officer, said the Macau approval reflects the strong clinical and regulatory foundation supporting Anktiva in this patient population.

He noted that the company’s focus remains on expanding global access to an immunotherapy designed to address the immune deficit underlying bladder cancer.

Beyond Macau, ImmunityBio continues to engage with health authorities across Asia as part of its broader international regulatory strategy.

Expanding applications

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, pointing to a growing range of potential applications for the therapy.