On 4 December 2024, Merus announced that the FDA has approved Bizengri® (zenocutuzumab-zbco) for adults with pancreatic adenocarcinoma or non-small cell lung cancer (NSCLC) that is advanced unresectable or metastatic and has an NRG1 gene fusion. According to Merus, this is the first and only approved treatment for this indication.
The accelerated FDA approval was based on overall response rate (ORR) and duration of response (DOR) in the eNRGy trial. Continued approval of the drug may be subject to a confirmatory clinical study.
This follows Merus’ announcement on 2 December 2024 that it has entered a licence agreement granting Partner Therapeutics US commercialisation rights for zenocutuzumab for the treatment of NRG1 fusion positive cancer.