Merus granted Breakthrough Therapy Designation for zenocutuzumab

Merus announced that the FDA has granted Breakthrough Therapy Designation, or BTD, for zenocutuzumab for the treatment of patients with advanced unresectable or metastatic NRG1 fusion, or NRG1+, non-small cell lung cancer, or NSCLC, following progression with prior systemic therapy. This designation for Zeno follows BTD for the treatment of patients with NRG1+ pancreatic cancer, following progression with prior systemic therapy or in patients who have no satisfactory alternative treatment options recently announced on June 30, Fast Track Designation for the treatment of patients with metastatic solid tumors harboring NRG1 gene fusions that have progressed on standard of care therapy announced in January 2021 and Orphan Drug Designation for the treatment of patients with pancreatic cancer announced in July 2020.