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 …
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.
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 …
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.
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.
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 …
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: …
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.
Zenocutuzumab Now FDA-Approved in NRG1+ NSCLC and Pancreatic …
Dec 4, 2024 · The FDA has approved zenocutuzumab (formerly MCLA-128) for the treatment of patients with neuregulin 1 fusion (NRG1+) non–small cell lung cancer (NSCLC) and NRG1+ pancreatic ductal …