The FDA has approved Bizengri for adults with advanced, unresectable or metastatic cholangiocarcinoma harboring a neuregulin 1 gene fusion whose disease progressed on or after prior systemic therapy.
Bizengri is the first approved treatment for patients with NRG1 fusion-positive cholangiocarcinoma, an ultra-rare cancer that forms in the bile ducts, according to a May 8 FDA release. The approval marks the seventh issued under the FDA Commissioner’s National Priority Voucher pilot program.
The drug’s efficacy was evaluated in a single-arm trial of 19 patients with NRG1 fusion-positive cholangiocarcinoma. Among participants, 36.8% had an overall response, with response durations ranging from 2.8 months to 12.9 months.
The approval comes ahead of a June 4 FDA public meeting on the National Priority Voucher pilot program, which was launched in June 2025 to accelerate reviews of drugs and biologics tied to national health priorities. The meeting will gather feedback on the program’s eligibility criteria, voucher selection process, sponsor responsibilities and FDA review procedures. The agency said written comments will be accepted through June 29.
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