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FDA Green Lights Bizengri Drug To Treat Rare, Aggressive Bile Duct Cancer
- May 11, 2026
- Andria Park Huynh HealthDay Reporter
The U.S. Food and Drug Administration (FDA) has approved Bizengri to treat an ultra-rare, aggressive cancer that forms in the bile ducts.
Bizengri (zenocutuzumab-zbco) is the first drug approved for adults with advanced, inoperable or metastatic cholangiocarcinoma with NRG1 gene fusion, the FDA announced.
NRG1, or neuregulin 1, gene fusions occur when two parts of a cell's DNA join together (or fuse) – an action that signals cells to grow abnormally, according to the American Lung Association. This leads to the growth of cancer cells.
Friday’s approval follows the FDA's 2024 approval for Bizengri to treat adults with advanced, metastatic or inoperable non-small cell lung cancer and pancreatic cancer.
Cholangiocarcinoma has been a clinical challenge, according to Cleveland Clinic, with inadequate, and largely ineffective, options for those battling the disease after initial treatment.
Last week’s approval is the seventh granted under the Commissioner’s National Priority Voucher (CNPV) pilot program for accelerated drug review and approval.
“Patients with this ultra-rare type of cancer desperately need new treatment options,” FDA Commissioner Dr. Marty Makary said in a news release. “Through the national priority voucher pilot program, the FDA is accelerating therapies for rare diseases with unmet medical needs, reviewing applications in significantly shortened timelines."
In one trial of 19 adults with NRG1 fusion-positive cholangiocarcinoma, 37% responded to the drug. The length of response ranged from about three months to 13, according to the FDA.
Serious side effects associated with Bizengri include infusion-related reactions, interstitial lung disease or pneumonitis, as well as left ventricular dysfunction, a condition in which the heart is unable to pump blood effectively to the body.
More common side effects include aches, digestive upsets, fatigue and edema.
The FDA granted the approval to Partner Therapeutics, Inc.
More information
There’s more about cholangiocarcinoma at the Mayo Clinic.
SOURCE: U.S. Food and Drug Administration, news release, May 8, 2026
