Zenocutuzumab

FDA extends review of Merus' bispecific antibody zenocutuzumab, targeting non-small cell lung cancer and pancreatic ductal adenocarcinoma with specific genetic mutations, due to additional CMC information submission. New action date set for Feb. 4, 2025. No clinical data issues identified. Zenocutuzumab disrupts HER2 and HER3 binding to inhibit cancer cell proliferation. Merus also developing petosemtamab for head and neck squamous cell carcinoma and metastatic colorectal cancer.

The FDA extended the PDUFA target action date for zenocutuzumab's BLA to February 4, 2025, for NRG1+ NSCLC and pancreatic cancer. Priority review was granted in May 2024, with additional time needed for chemistry, manufacturing, and controls assessment.

The FDA extended the review period for Merus N.V.'s biologics license application for zenocutuzumab in NRG1 fusion–positive cancer to February 4, 2025, to review submitted Chemistry, Manufacturing, and Controls information without requesting additional clinical data.

The FDA extended the PDUFA target action date for the BLA of zenocutuzumab (MCLA-128) for NRG1-positive NSCLC and pancreatic cancer to February 4, 2025, due to additional CMC review. The BLA is supported by the eNRGy trial data showing ORR of 37.2% in NSCLC and 42.4% in PDAC, with no treatment-related TEAEs leading to discontinuation.

Merus N.V. announced the FDA extended the PDUFA goal date for zenocutuzumab's BLA to February 4, 2025, to review additional CMC information. No extra clinical data were requested. Merus aims for a commercialization partnership to bring Zeno to NRG1+ cancer patients, pending approval.

Merus N.V. announced the FDA extended the PDUFA goal date for zenocutuzumab's BLA to February 4, 2025, to review additional CMC information. No extra clinical data were requested. Merus aims to secure a commercialization partnership to bring Zeno to NRG1+ cancer patients, pending approval.