The latest marketing progress of Zenocutuzumab in 2025

As of20257 months, Zenocutuzumab (Zenocutuzumab, trade name: Bizengri) has been approved by the U.S. Food and Drug Administration (FD A) for the treatment of patients with advanced non-small cell lung cancer (NSCLC) and pancreatic ductal adenocarcinoma (PDAC) who carry NRG1 gene fusions. This marks the drug becoming the first HER2/HER3 bispecific antibody drug approved for marketing in the world.

Zetolizumab was developed by the Dutch biopharmaceutical company Merus and targets the HER3 receptor, aiming to block the abnormal signaling pathways caused by NRG1 gene fusion. In the eNRGy clinical trial, approximately 33% of patients with advanced NSCLC harboring NRG1 fusions experienced significant tumor shrinkage, and the median duration of response was < span> 11 months

FDA's approval is based on the drug's efficacy data in clinical trials. However, as an accelerated approval, Merus The company needs to conduct further studies to confirm its clinical benefits, including extending patient survival. Additionally, common side effects of zetolizumab include diarrhea, musculoskeletal pain, fatigue, nausea, infusion-related reactions, shortness of breath, rash, constipation, vomiting, abdominal pain, and edema.

Currently, zetolizumab has not been approved for marketing in China. If patients want to use the drug, they may need to go to the United States for medical treatment. As the drug is promoted globally, it is expected that more research results on its efficacy and safety will be released in the future, providing patients with more treatment options.

Reference materials:https://www.drugs.com/