FDA Brief: Zenocutuzumab Granted Fast Track Designation for NRG1 Fusion Cancers
Posted: Wednesday, January 20, 2021
On January 7, the U.S. Food and Drug Administration (FDA) granted Fast Track designation to zenocutuzumab for the treatment of patients with metastatic solid tumors with neuregulin 1 (NRG1) gene fusions that progressed from a standard-of-care therapy.
The drug is currently being investigated in the currently enrolling phase I/II eNRGy trial of patients with NRG1 gene fusion–positive solid tumors (eg, non–small cell lung cancer, breast cancer, and ovarian cancer).
