US FDA Grants Seventh Approval under the National Priority Voucher Pilot Program

United States, May 11 -- The U.S. Food and Drug Administration issued an approval for Bizengri (zenocutuzumab-zbco), a drug that treats NRG1 fusion-positive cholangiocarcinoma, an ultra-rare, aggressive cancer that forms in the bile ducts. Bizengri is the first drug approved for adults with advanced, unresectable or metastatic cholangiocarcinoma harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy.This approval marks the seventh approval under the Commissioner's National Priority Voucher (CNPV) pilot program. The efficacy of Bizengri was evaluated in a single-arm trial of 19 patients with NRG1 fusion-positive cholangiocarcinoma of which 36.8% had an overall response. The duration of respons...