FDA approved Bizengri (zenocutuzumab) for NRG1 Fusion-Positive NSCLC and Pancreatic CancerFDA approved new drug Bizengri for two rare lung and pancreatic cancers.

FDA From the archive Source published December 4, 2024 Summary added May 14, 2026 DOI ↗ Editorial oversight: Dr. Julia Lee, PhD · Oncology, Genomics & Drug Development

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Key Takeaway

Consider Bizengri for advanced NRG1 fusion-positive NSCLC or pancreatic cancer after prior therapy, with accelerated approval based on response rates.

The FDA has approved Bizengri (zenocutuzumab), a bispecific HER2- and HER3-directed antibody, for the treatment of adults with advanced, unresectable or metastatic non-small cell lung cancer (NSCLC) harboring a neuregulin 1 (NRG1) gene fusion, with disease progression on or after prior systemic therapy. The same approval covers adults with advanced, unresectable or metastatic pancreatic adenocarcinoma harboring an NRG1 gene fusion, also after prior systemic therapy. Both indications were approved under accelerated approval based on overall response rate and duration of response; continued approval may depend on confirmatory trials. Clinicians should select patients based on the presence of an NRG1 gene fusion in tumor specimens, though no FDA-approved test is currently available. The approval addresses a rare molecular subset of these cancers with limited treatment options.

＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)

Mechanism of Action

Bizengri is a bispecific HER2- and HER3-directed antibody. It binds to HER2 and HER3, inhibiting neuregulin 1 (NRG1) signaling.

Indication & Patient Population

Bizengri is indicated for adults with advanced, unresectable or metastatic NSCLC harboring an NRG1 gene fusion with disease progression on or after prior systemic therapy. Also indicated for adults with advanced, unresectable or metastatic pancreatic adenocarcinoma harboring an NRG1 gene fusion with disease progression on or after prior systemic therapy. Both indications are approved under accelerated approval based on overall response rate and duration of response.

Dosing & Administration

Select patients based on NRG1 gene fusion in tumor specimens. Evaluate left ventricular ejection fraction (LVEF) before initiating. Recommended dosage is 750 mg intravenously every 2 weeks until disease progression or unacceptable toxicity. Administer premedications before each infusion: corticosteroid (e.g., dexamethasone 10 mg), antipyretic (acetaminophen 1000 mg), and H1 antihistamine (e.g., dexchlorpheniramine 5 mg). Infuse over 4 hours after dilution. No dose reductions; modify dosing for adverse reactions per label tables.

Key Clinical Trial Data

Trial data not available in label.

Warnings & Contraindications

Warnings include infusion-related reactions (IRRs), interstitial lung disease/pneumonitis, and left ventricular dysfunction. For IRRs: interrupt infusion for ≤ Grade 3, resume at 50% rate; permanently discontinue for Grade 4 or any hypersensitivity/anaphylaxis. For ILD/pneumonitis: interrupt for Grade 1, permanently discontinue for ≥ Grade 2. For left ventricular dysfunction: interrupt if LVEF 45-49% with ≥10% absolute decrease from baseline or LVEF <45%; permanently discontinue if symptomatic CHF or if LVEF does not recover. No contraindications listed in label.

Place in Therapy

Bizengri is a targeted therapy for NRG1 fusion-positive NSCLC and pancreatic adenocarcinoma after prior systemic therapy. It addresses an unmet need in these rare molecular subtypes. Approval is accelerated, pending confirmatory trials.

The FDA has approved a new drug called Bizengri (zenocutuzumab) for adults with two rare types of cancer that have a specific genetic change. This change is called an NRG1 gene fusion. The drug is for people with advanced non-small cell lung cancer or pancreatic cancer that has spread or cannot be removed by surgery. It is for patients whose cancer has gotten worse after other treatments.

Bizengri is a type of targeted therapy called a bispecific antibody. It works by attaching to two different proteins on cancer cells, HER2 and HER3, to help stop the cancer from growing. The approval is based on studies showing that the drug shrank tumors in some patients. The FDA granted this approval under an accelerated process, which means the company must do more studies to confirm the benefit.

This approval is important because these cancers with an NRG1 fusion are very rare and have had few treatment options. However, there is currently no FDA-approved test to find the NRG1 fusion. Doctors may use other tests to decide if a patient might benefit.

If you or a loved one has advanced lung or pancreatic cancer, talk to your doctor about whether testing for an NRG1 fusion might be right for you. This drug is not for everyone, and your doctor can help you understand if it could be a possible treatment option.

What this means for you:

Bizengri is a new targeted drug for rare lung and pancreatic cancers with an NRG1 fusion; talk to your doctor about testing.

Study Details

Study typeFda approval

PublishedDec 2024

View Original Abstract ↓

1 INDICATIONS AND USAGE BIZENGRI® is a bispecific HER2- and HER3-directed antibody indicated for the treatment of: Adults with advanced, unresectable or metastatic non-small cell lung cancer (NSCLC) harboring a neuregulin 1 ( NRG1 ) gene fusion with disease progression on or after prior systemic therapy.* ( 1.1 ) Adults with advanced, unresectable or metastatic pancreatic adenocarcinoma harboring a neuregulin 1 ( NRG1 ) gene fusion with disease progression on or after prior systemic therapy.* ( 1.2 ) *This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). 1.1 Advanced Unresectable or Metastatic NRG1 Fusion-Positive Non-Small Cell Lung Cancer BIZENGRI is indicated for the treatment of adults with advanced unresectable or metastatic non-small cell lung cancer (NSCLC) harboring a neuregulin 1 ( NRG1 ) gene fusion with disease progression on or after prior systemic therapy. This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies ( 14.1 )]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). 1.2 Advanced Unresectable or Metastatic NRG1 Fusion-Positive Pancreatic Adenocarcinoma BIZENGRI is indicated for the treatment of adults with advanced unresectable or metastatic pancreatic adenocarcinoma harboring a neuregulin 1 ( NRG1 ) gene fusion with disease progression on or after prior systemic therapy. This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies ( 14.2 )] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

FDA approved Bizengri (zenocutuzumab) for NRG1 Fusion-Positive NSCLC and Pancreatic CancerFDA approved new drug Bizengri for two rare lung and pancreatic cancers.

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FDA approved Bizengri (zenocutuzumab) for NRG1 Fusion-Positive NSCLC and Pancreatic CancerFDA approved new drug Bizengri for two rare lung and pancreatic cancers.

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