← Back to The Docket MAY 8 2026
APPROVED · 144 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
Bizengri is a bispecific antibody that physically blocks the interaction between the NRG1 protein and its HER3 receptor on cancer cells. By interrupting this specific growth signal, the drug aims to stop the uncontrolled cell division that defines NRG1 fusion-positive cholangiocarcinoma. This targeted approach may offer a new treatment option for this aggressive form of bile duct cancer.
