Overview
- Macau’s Pharmaceutical Administration Bureau approved Anktiva with BCG for adults with BCG‑unresponsive non‑muscle invasive bladder cancer with carcinoma in situ, with or without papillary tumors, marking ImmunityBio’s first approval in Asia.
- ImmunityBio says it is preparing for commercial distribution in Macau and is in talks with other Asia‑Pacific regulators as it pursues a broader regional rollout.
- The 2026 U.S. NCCN guidelines now recommend Anktiva plus BCG for patients who have papillary‑only disease as a Category 2A option, which is not yet included in the current FDA‑approved label.
- Regulators and guideline bodies have cited QUILT‑3.032 data showing a 71% complete response rate and a 26.6‑month median response duration in BCG‑unresponsive carcinoma in situ.
- The company reports growing U.S. adoption, pointing to a permanent J‑code, coverage for more than 100 million insured patients, and 2025 revenue rising to $113 million.