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.
NRG1 fusion-driven tumors: biology, detection and the therapeutic …
A substantial proportion (≈20%) of NRG1 fusion-positive non-small-cell lung cancer (NSCLC) cases are non-mucinous adenocarcinomas. ErbB-targeted treatments, such as afatinib, a pan-ErbB tyrosine …
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 …
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 …
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 …
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.
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.
First Systemic Therapy Approved for Lung and Pancreatic Cancers …
The trial enrolled patients with advanced or metastatic NRG1 fusion-positive NSCLC (64 patients) or pancreatic adenocarcinoma (30 patients) who had experienced disease progression on other …
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: …
FDA Approves First and Only Systemic Therapy for NRG1+ Lung, …
Dec 4, 2024 · The FDA granted accelerated approval to zenocutuzumab-zbco as the first systemic therapy for patients with lung or pancreatic cancers harboring an NRG1 gene fusion. Previously, the …