ImmunityBio has announced that the Pharmaceutical Administration Bureau (ISAF) of the Macau Special Administrative Region has approved ANKTIVA, marking the drug’s debut in Asia.
The approval allows ANKTIVA (nogapendekin alfa inbakicept-pmln), to be used in combination with Bacillus Calmette-Guérin (BCG) for adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors—mirroring its approved use in the United States.
The Macau authorization followed a regulatory review that considered prior decisions by both the US FDA) and the European Medicines Agency (EMA).
“This approval in Macau reflects the strength of the clinical and regulatory foundation supporting ANKTIVA in BCG-unresponsive NMIBC CIS, with or without papillary tumors,” said Patrick Soon-Shiong, Founder, Executive Chairman, and Global Chief Scientific and Medical Officer of ImmunityBio.
“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.”
The Macau approval is the first in Asia, as ImmunityBio advances its international regulatory strategy across the region.
“This authorization marks an important step in establishing ANKTIVA in Asia and advancing our broader international expansion strategy,” said Richard Adcock, President and CEO of ImmunityBio.
“We are engaging with additional health authorities across the Asia-Pacific region and, in parallel, beginning to prepare for potential commercial distribution, recognizing there is still meaningful work ahead as we pursue further regulatory authorizations. Our focus is on executing this expansion in a disciplined manner, building on our existing approvals to support long-term global access for patients.”
