← Back to The Docket MAY 8 2026
APPROVED · 26 DAYS AGO
— Bizengri (zenocutuzumab-zbco)
for NRG1 fusion-positive cholangiocarcinoma
BLA
FDA granted approval to Partner Therapeutics' Bizengri (zenocutuzumab-zbco) for NRG1 fusion-positive cholangiocarcinoma under the FDA Commissioner's National Priority Voucher (CNPV) pilot program — the seventh CNPV approval. Same drug received the CNPV award on 2026-05-06; approval landed 2 days later.
About
Cholangiocarcinoma is a rare and aggressive bile duct cancer that often goes undetected until advanced stages, when treatment options are limited. Bizengri (zenocutuzumab-zbco) is an antibody that targets and blocks NRG1 fusion proteins, which can drive tumor growth in certain cancers. By neutralizing these abnormal signals, the drug may help slow cancer progression in patients with this specific genetic alteration.
