Overview
- ImmunityBio received authorization from Macau’s Pharmaceutical Administration Bureau to market Anktiva with BCG for adults with non–muscle invasive bladder cancer that no longer responds to BCG and includes carcinoma in situ, with or without papillary tumors.
- The clearance is the company’s first in Asia and the firm said it is engaging other regulators across the region as it builds out international access.
- ISAF said its review drew on earlier decisions by the U.S. Food and Drug Administration and the European Medicines Agency, a common approach smaller regulators use to speed evaluations.
- Clinical data from the QUILT‑3.032 study reported a 71% complete response rate and a 26.6‑month median duration of response for Anktiva plus BCG in the target patient group.
- The National Comprehensive Cancer Network recently added Anktiva plus BCG as a Category 2A option for patients with papillary‑only disease, a use the company notes is not yet in the FDA‑approved label.