A Cancer Driven by Ultra-Rare Mutation Gets Its First FDA-Approved Therapy

FDA green lights Bizengri drug to treat rare, aggressive bile duct cancer

The U.S. Food and Drug Administration (FDA) has approved Bizengri to treat an ultra-rare, aggressive cancer that forms in the bile ducts.

A Cancer Driven by Ultra-Rare Mutation Gets Its First FDA-Approved Therapy

Partner Therapeutics’ Bizengri is now FDA approved for treating advanced cases of cholangiocarcinoma driven by NRG1 gene fusions. Partner acquired U.S. rights to this bispecific antibody from Merus in 2024.

Partner Therapeutics Announces FDA Approval of BIZENGRI® (Zenocutuzumab-zbco) for NRG1 Fusion-Positive Cholangiocarcinoma Following Receipt of FDA Commissioner's National Priority Voucher

First Targeted Therapy Approved for NRG1+ Cholangiocarcinoma

Partner's Bizengri is first drug for rare, aggressive cancer

Partner's Bizengri has been approved for a rare form of bile duct cancer, two days after being awarded a national priority review voucher.

Partner Therapeutics secures FDA approval for Bizengri

Partner Therapeutics has received FDA approval for Bizengri to treat adults with advanced, unresectable or metastatic cholangiocarcinoma harbouring an NRG1 gene fusion and who have progressed on or after prior systemic therapy.

FDA Approves Bizengri for Rare Bile Duct Cancer

WASHINGTON, D.C. — The U.S. Food and Drug Administration has approved Bizengri for adults with advanced NRG1 fusion-positive cholangiocarcinoma, marking the first approved treatment for the rare bile duct cancer after progression on prior systemic therapy. The approval covers patients with unresectable or metastatic cholangiocarcinoma harboring a neuregulin 1 gene fusion. The FDA said the decision was made under the agency’s Commissioner’s Natio…