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ImmunityBio Announces Approval in Macau SAR, China for ANKTIVA® in BCG-Unresponsive NMIBC with CIS ± Papillary Tumors
Macau SAR, China regulator grants approval for ANKTIVA® (nogapendekin alfa inbakicept-pmln) in patients with BCG-unresponsive NMIBC with CIS ± papillary
About this update from Immunitybio, Inc.
[{"type":"text","content":"\n\nMacau SAR, China regulator grants approval for ANKTIVA® (nogapendekin alfa inbakicept-pmln) in patients with BCG-unresponsive NMIBC with CIS ± papillary tumors\n\n\n\nAuthorization follows a reliance-based review referencing prior FDA and EMA decisions\n\n\n\nFirst ANKTIVA authorization in Asia, supporting ongoing global expansion across 34 countries and territories\n\n\n\n CULVER CITY, Calif.--(BUSINESS WIRE)--\nImmunityBio, Inc. (NASDAQ: IBRX), today announced that the Pharmaceutical Administration Bureau (ISAF) of the Macau Special Administrative Region of the People’s Republic of China has granted regulatory approval for ANKTIVA® (nogapendekin alfa inbakicept-pmln).\n\n\nThe approval establishes ANKTIVA’s initial presence in Asia and reflects the Company’s strategy to expand global access through reliance-based regulatory pathways. In Macau, ANKTIVA is approved in combination with Bacillus Calmette-Guérin (BCG) for adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) ± papillary tumors, consistent with its approved use in the United States.\n\n\nThe authorization was granted following a review that considered prior regulatory decisions by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), in accordance with applicable local requirements.\n\n\n“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, M.D., 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.”\n\n\nThis approval in Macau represents the first authorization for ANKTIVA in Asia. The Company continues to engage with additional health authorities across the region as part of its international regulatory strategy.\n\n\n“This authorization marks an important step in establishing ANKTIVA in Asia and advancing our broader international expansion st...