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  1. Bizengri Approved to Treat Some Lung, Pancreatic Cancers

    Mar 26, 2025 · FDA has approved zenocutuzumab (Bizengri) to treat lung and pancreatic cancers with a rare genetic alteration called an NRG1 fusion.

  2. Zenocutuzumab-zbco (BIZENGRI®) Shows Durable Efficacy in Patients …

    1 day ago · ADVERSE REACTIONS NRG1 Gene Fusion Positive Unresectable or Metastatic NSCLC Serious adverse reactions occurred in 25% of patients with NRG1 gene fusion positive NSCLC who …

  3. FDA grants accelerated approval to zenocutuzumab-zbco

    Dec 4, 2024 · The trial enrolled 64 adults with advanced or metastatic NRG1 fusion-positive NSCLC and 30 adults with advanced or metastatic NRG1 fusion-positive pancreatic adenocarcinoma who had …

  4. Zenocutuzumab: A Novel Bispecific Antibody for NRG1 Fusion-Positive ...

    Feb 6, 2025 · On December 4, 2024, the U.S. Food and Drug Administration granted accelerated approval to zenocutuzumab (Bizengri®), the first approved systemic therapy for patients with …

  5. Analysis on the pathogenesis and treatment progress of NRG1 fusion ...

    Jun 18, 2024 · This review provides a concise overview of NRG1, including its expression patterns, configuration, and fusion partners. Additionally, we explore the unique features and potential …

  6. Trial Supports Bizengri as a Promising Treatment for NRG1 Fusion ...

    Apr 3, 2025 · A new study validates NRG1 gene fusions as a targetable driver of advanced NRG1 fusion-positive cancers, adding support for Bizengri (zenocutuzumab) as a promising treatment option.

  7. FDA approves Bizengri: NRG1 gene Fusions in Lung and Pancreas

    Dec 9, 2024 · This is the first approved systemic therapy targeting NRG1 gene fusions, a rare but actionable driver mutation in certain cancers. Zenocutuzumab-zbco is approved for adults with: …

  8. NRG1 Fusions Emerge as New Target of Interest in Lung, Pancreatic ...

    Dec 17, 2024 · NRG1 fusion positivity has gained interest as a treatment target in lung and pancreatic cancer, leading to the FDA approval of zenocutuzumab in December 2024.

  9. What the FDA Approval of Bizengri Means for Patients With NRG1-Positive

    Mar 6, 2025 · The Food and Drug Administration (FDA) has granted its first approval for a systemic therapy for patients with non-small cell lung cancer (NSCLC) with an Neuregulin 1 (NRG1) gene …

  10. Comprehensive identification of NRG1 fusions in 25,203 patients with ...

    Jul 29, 2025 · NRG1 fusion is an emerging oncogenic driver, and the FDA has approved drugs for the treatment of non-small cell lung cancer and pancreatic cancer associated with NRG1 fusions.