ImmunityBio announces approval in Macau for Anktiva

ImmunityBio (IBRX) announced that the Pharmaceutical Administration Bureau of the Macau Special Administrative Region of the People’s Republic of China has granted regulatory approval for Anktiva. “The 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-Guerin for adult patients with BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ +/- papillary tumors, consistent with its approved use in the United States. The authorization was granted following a review that considered prior regulatory decisions by the U.S. Food and Drug Administration and the European Medicines Agency, in accordance with applicable local requirements,” the company stated.