ImmunityBio has received regulatory approval from the Pharmaceutical Administration (ISAF) of the Macau Special Administrative Region of China for ANKTIVA (nogapendekin alfa inbakicept-pmln).[1][2] ANKTIVA is approved in combination with Bacillus Calmette-Guérin (BCG) for adult patients with BCG-mismatched non-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.[1][2] The approval is based on a review that takes into account previous FDA and EMA decisions.[1] This is ANKTIVA's first approval in Asia, supporting global expansion in 34 countries and territories.[1] The approval stems from the QUILT-3.032 clinical trial, where 71 percent of patients with BCG-refractory NMIBC with CIS and/or papillary tumors achieved a complete response.[2] The median duration of response in this study was 26.6 months.[2] This approval is consistent with the use of ANKTIVA in the US.[1]