In this article
On November 20, 2024, the Food and Drug Administration granted accelerated approval for zanidatamab-hrii (Ziihera, Jazz Pharmaceuticals, Inc.), a bispecific HER2-targeted antibody, for previously treated, unresectable, or metastatic HER2-positive (IHC 3+) biliary tract cancer (BTC), as identified by an FDA-approved assay.
Today, the FDA authorized the VENTANA PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody (Ventana Medical Systems, Inc./Roche Diagnostics) as a companion diagnostic tool to assist in identifying patients with BTC who may qualify for therapy with Ziihera.
The efficacy was assessed in HERIZON-BTC-01 (NCT04466891), an open-label, multicenter, single-arm trial involving 62 patients with unresectable or metastatic HER2-positive (IHC3+) biliary tract cancer (BTC). Patients were mandated to have undergone a minimum of one previous gemcitabine-based treatment in the context of advanced illness.
The primary efficacy endpoints were the objective response rate (ORR) and the duration of response (DOR), assessed by an independent central review in accordance with RECIST v1.1. The overall response rate (ORR) was 52% (95% confidence interval: 39, 65), and the median duration of response (DOR) was 14.9 months (95% confidence interval: 7.4, not estimable).
How CancerFax Helps
CancerFax is a specialist cancer access and patient-navigation platform. We help patients and families understand their options, organise medical records, coordinate hospital communication, and support cross-border treatment planning where appropriate.
We help collect and organise reports, scans, pathology, biomarker results, and treatment history for structured case review.
We communicate with hospitals or trial teams to assess whether a case may be suitable for further screening.
We support appointment coordination, document submission, translation, and direct communication with international departments.
For international patients, we help with practical coordination — travel planning, hospital admission guidance, and local support.
If this option is not suitable, we help explore other relevant treatments, clinical trials, or advanced care pathways.
From inquiry through to follow-up, our coordinators provide a single point of contact for the family.
CancerFax does not guarantee treatment access, eligibility, or clinical outcome. Our role is to help patients access accurate information, structured review, and appropriate specialist pathways.
About Dr. Nishant Mittal
Dr. Nishant Mittal is a highly accomplished researcher with over 13 years of experience in the fields of cardiovascular biology and cancer research. Significant contributions to stem cell biology, developmental biology, and innovative research techniques mark his career. Research Highlights Dr. Mittal's research has focused on several key areas: 1) Cardio…
✓ Reviewed for medical accuracy by the CancerFax review panel.
Medical Disclaimer
This article is for educational purposes only and should not replace medical advice, diagnosis, or treatment from a qualified oncology specialist. Every patient's case is different. Treatment decisions should always be made after a review of complete medical records by the treating medical team.
Treatment availability, eligibility, timelines, and access can change. Any clinical trial participation depends on detailed review and approval by the trial hospital or investigator.