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MAY 8 2026
APPROVED · 84 DAYS AGO

Partner Therapeutics 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 cancer-driving NRG1 protein from activating the HER3 receptor on tumor cells. By interrupting this specific growth signal, the drug aims to slow or stop the progression of NRG1 fusion-positive cholangiocarcinoma. This targeted approach may offer a new treatment option for patients with this form of bile duct cancer.