Posted by Michael Wonder on 07 Dec 2024
FDA grants accelerated approval to zenocutuzumab-zbco for non-small cell lung cancer and pancreatic adenocarcinoma
4 December 2024 - This represents the first FDA approval of a systemic therapy for patients with non-small cell lung cancer or pancreatic adenocarcinoma harbouring an NRG1 gene fusion.
Today, the FDA granted accelerated approval to zenocutuzumab-zbco (Bizengri, Merus) for adults with the following:
- Advanced, unresectable, or metastatic non-small cell lung cancer harbouring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy, or
- Advanced, unresectable, or metastatic pancreatic adenocarcinoma harbouring a NRG1 gene fusion with disease progression on or after prior systemic therapy
