Overview
- Regulators cleared Bizengri for adults with advanced cholangiocarcinoma that carries an NRG1 gene fusion after prior systemic therapy.
- The decision used the FDA Commissioner’s National Priority Voucher pilot, with this approval reported as the seventh granted through the program.
- Evidence came from the eNRGy Phase 2 study, which enrolled 22 patients and found a 36.8% response rate among 19 evaluable patients with responses lasting 2.8 to 12.9 months.
- The prescribing information includes a boxed warning for embryo‑fetal toxicity, and common side effects included diarrhea, nausea, abdominal pain, shortness of breath, and musculoskeletal pain.
- The indication was granted under accelerated approval based on tumor shrinkage and durability, and ongoing confirmatory trials will need to verify clinical benefit as clinicians expand testing to identify rare NRG1 fusions.