FDA Approves Zenocutuzumab-zbco for Advanced, Unresectable or Metastatic Cholangiocarcinoma

The U.S. Food and Drug Administration (FDA) has approved zenocutuzumab-zbco (Bizengri) for adults with advanced, unresectable or metastatic cholangiocarcinoma harboring a neuregulin 1 (NRG1) gene fusion whose disease progressed on or after prior systemic therapy.

The approval was announced by the agency on May 8, 2026, and applies to patients whose bile duct cancer cannot be removed with surgery or has spread to other parts of the body. According to the FDA, NRG1 fusion-positive cholangiocarcinoma is an extremely rare form of the disease.

The FDA reviewed the application through the FDA Commissioner’s National Priority Review Voucher pilot program, which is intended to speed the review of therapies that may address important national health priorities. The agency approved the application more than five months ahead of its goal date.

Zenocutuzumab-zbco also received previously breakthrough therapy designation, orphan drug designation and priority review from the FDA.

What data supported the FDA Approval of zenocutuzumab-zbco?

The approval was based on findings from the eNRGy clinical trial, which evaluated zenocutuzumab-zbco in patients with advanced solid tumors harboring NRG1 gene fusions.

Among patients with unresectable or metastatic NRG1 fusion-positive cholangiocarcinoma, the treatment demonstrated an overall response rate (ORR) of 36.8%.

Responses to treatment lasted from 2.8 months to 12.9 months.

The prescribing information states that patients receive the treatment as a 750 mg intravenous infusion every two weeks until disease progression or unacceptable toxicity occurs.

What were the details of the eNRGy trial?

A total of 22 patients with unresectable or metastatic NRG1 fusion-positive cholangiocarcinoma enrolled in the trial. Of those patients, 19 were evaluable for efficacy.

The FDA also stated that the review process used the Assessment Aid, which is a voluntary submission provided by the applicant to help facilitate the FDA’s evaluation of the treatment application.

What side effects were reported with zenocutuzumab-zbco?

The prescribing information for zenocutuzumab-zbco includes warnings and precautions for infusion-related reactions, hypersensitivity reactions, anaphylactic reactions, interstitial lung disease/pneumonitis, left ventricular dysfunction and embryo-fetal toxicity.

The most common side effects reported with the treatment included diarrhea, musculoskeletal pain, fatigue, nausea, infusion-related reactions, dyspnea, rash, constipation, vomiting, abdominal pain, and edema.

Patients receiving treatment with zenocutuzumab-zbco are monitored for side effects throughout therapy, particularly because some side effects may become serious or require treatment interruption or discontinuation.

References

1. “FDA approves zenocutuzumab-zbco for advanced, unresectable or metastatic cholangiocarcinoma,” U.S. Food and Drug Administration.