Is Zenocutuzumab currently on the market?

Zenocutuzumab is a bispecific antibody drug targeting HER2/HER3, developed by Merus, a Dutch biopharmaceutical company. It is mainly used to treat patients with solid tumors carrying NRG1 gene fusion, especially advanced malignant tumors such as non-small cell lung cancer (NSCLC) and pancreatic ductal adenocarcinoma (PDAC). NRG1 fusion is a rare but strongly driven genetic abnormality. Traditional treatments often have limited efficacy. Therefore, zetolizumab, as the first systemic drug to treat this mutation, has attracted much attention in clinical research.

Up to now, zetolizumab has been approved by the United States in202412 month The FDA has accelerated its approval for the treatment of adult patients with advanced non-small cell lung cancer and pancreatic cancer who have progressed despite prior systemic therapy and carry NRG1 fusions. Its approval was based on the results of the Phase II clinical study of eNRGy. In this study, patients showed good response rates and disease control times, making it an important breakthrough in the treatment of NRG1 fusion tumors.

Zetolizumab's therapeutic mechanism is based on its highly selective inhibition of the HER2 and HER3 signaling pathways, thereby effectively blocking tumor growth driven by NRG1 fusion. This innovative mechanism also makes it the world's first dual-antibody targeted drug specifically developed for the fusion of HER3 and NRG1. According to public clinical data, zetolizumab has produced objective relief in some advanced patients, and most of the side effects are controllable mild to moderate gastrointestinal discomfort and fatigue.

However, currently, zetolizumab has not yet been officially launched in mainland China or most other countries, and there is no marketing information approved by NMPA (State Food and Drug Administration) in China. If patients need medicine, they can only obtain it through overseas medical treatment, clinical trials or cross-border drug purchase. With the advancement of international marketing and the accumulation of more clinical data, the drug is expected to be approved in more countries in the future. Especially for NRG1 fusion carriers, this will be an important new option for targeted therapy.

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