Posted by Michael Wonder on 29 Jun 2023
Zenocutuzumab granted breakthrough therapy designation by the US FDA for the treatment of NRG1+ pancreatic cancer
29 June 2023 - Merus today announced that the US FDA has granted breakthrough therapy designation for zenocutuzumab for the treatment of patients with advanced unresectable or metastatic NRG1 fusion (NRG1+) pancreatic cancer following progression with prior systemic therapy or who have no satisfactory alternative treatment options.
This designation for zenocutuzumab follows a fast track designation for the treatment of patients with metastatic solid tumours harbouring NRG1 gene fusions (NRG1+ cancer) that have progressed on standard of care therapy on 7 January 2021 and orphan drug designation for the treatment of patients with pancreatic cancer on 27 July 2020.
