FDA Approves Bizengri (zenocutuzumab) for NRG1 Fusion-Positive NSCLC and Pancreatic Cancer

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FDA Published May 14, 2026 Medically reviewed May 14, 2026 DOI ↗ By Dr. Julia Lee, PhD · Oncology, Genomics & Drug Development

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.

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).