In this article
- FDA Grants Accelerated Approval to Zenocutuzumab-zbco for NRG1 Fusion-Positive Non-Small Cell Lung Cancer and Pancreatic Adenocarcinoma
- ENRGy Trial – Efficacy of Zenocutuzumab-zbco in NRG1 Fusion-Positive NSCLC and Pancreatic Adenocarcinoma
- Adverse Effects and Recommended Dosage of Zenocutuzumab-zbco
- How CancerFax Helps
On December 4, 2024, the Food and Drug Administration granted accelerated approval to zenocutuzumab-zbco (Bizengri, Merus N.V.) for use in adults with specific conditions.
Patients with advanced, unresectable, or metastatic non-small cell lung cancer (NSCLC) exhibiting a neuregulin 1 (NRG1) gene fusion and experiencing disease progression following prior systemic therapy, or those with advanced, unresectable, or metastatic pancreatic adenocarcinoma with an NRG1 gene fusion and disease progression after prior systemic therapy.
This marks the inaugural FDA approval of a systemic therapy for patients with non-small cell lung cancer (NSCLC) or pancreatic adenocarcinoma that possess an NRG1 gene fusion.
The efficacy was assessed in the eNRGy study (NCT02912949), a multicenter, open-label, multicohort trial. The trial included 64 adults with advanced or metastatic NRG1 fusion-positive non-small cell lung cancer (NSCLC) and 30 adults with advanced or metastatic NRG1 fusion-positive pancreatic adenocarcinoma, all of whom experienced disease progression after standard care treatment. The positive NRG1 gene fusion status was prospectively identified using next-generation sequencing assays.
The primary efficacy outcome measures included the overall response rate (ORR) and duration of response (DOR), assessed through blinded independent central review in accordance with RECIST v1.1 guidelines. The overall response rate (ORR) for non-small cell lung cancer (NSCLC) was 33% (95% confidence interval: 22%, 46%), with a median duration of response (DOR) of 7.4 months (95% confidence interval: 4.0, 16.6). In pancreatic adenocarcinoma, the objective response rate (ORR) was 40% (95% confidence interval: 23%, 59%), with a duration of response (DOR) ranging from 3.7 months to 16.6 months.
The pooled safety population revealed that the most prevalent adverse reactions (≥10%) included diarrhea, musculoskeletal pain, fatigue, nausea, infusion-related reactions, dyspnea, rash, constipation, vomiting, abdominal pain, and edema. The predominant Grade 3 or 4 laboratory abnormalities (≥10%) included elevated gamma-glutamyl transferase, reduced hemoglobin, diminished sodium levels, and decreased platelet counts. The prescribing information contains a boxed warning regarding embryo-fetal toxicity.
The advised dosage of zenocutuzumab-zbco is 750 mg, administered as an intravenous infusion biweekly, continuing until disease progression or intolerable toxicity occurs.
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 Sai Sree
✓ 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.