ImmunityBio receives approval for ANKTIVA in Macau for bladder cancer

ImmunityBio Inc. (NASDAQ: IBRX) announced that the Pharmaceutical Administration Bureau of Macau Special Administrative Region granted regulatory approval for ANKTIVA (nogapendekin alfa inbakicept-pmln) for treating adult patients with BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ with or without papillary tumors.

The approval marks the first authorization for ANKTIVA in Asia and follows a reliance-based review that referenced prior decisions by the U.S. Food and Drug Administration and the European Medicines Agency. In Macau, ANKTIVA is approved for use in combination with Bacillus Calmette-Guérin, consistent with its approved use in the United States.

ANKTIVA is an interleukin-15 receptor agonist designed to activate natural killer cells and CD8+ T cells. In the QUILT-3.032 study involving patients with BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ, ANKTIVA combined with BCG demonstrated a complete response rate of 71% with a median duration of response of 26.6 months.

"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 and executive chairman of ImmunityBio.

The company stated it continues to engage with additional health authorities across the Asia-Pacific region as part of its international regulatory strategy, which spans 34 countries and territories. The approval supports the company's strategy to expand global access through reliance-based regulatory pathways, according to the press release statement.

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