Dutch biotechnology company Merus (NASDAQ: MRUS) has announced that the US Food and Drug Administration (FDA) has accepted for review its market approval filing for zenocutuzumab, a first-in-class HER2/HER3 bispecific antibody (BsAb), for the treatment of NRG1+ non-small cell lung cancer (NSCLC) and pancreatic cancer. The application has been granted priority review status by the FDA.
The filing for zenocutuzumab is supported by data from the Phase I/II eNRGy clinical study. Previously, in January 2018, China-based Simcere Pharmaceutical Group had entered into a licensing agreement with Merus for the rights to zenocutuzumab in China, which was later cancelled. Despite the cancellation of the agreement, Simcere still holds the rights to Merus’s EGFR/cMET bispecific antibody in China.- Flcube.com
