7 April 2020 - Immunomedics today announced that the U.S. FDA has granted fast track designation for sacituzumab govitecan for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor, and a platinum containing chemotherapy in the neo-adjuvant/adjuvant, locally advanced or metastatic setting, including patients who are platinum ineligible and have previously received a PD-1 or PD-L1 inhibitor in the neo-adjuvant/adjuvant, locally advanced, or metastatic setting.

Sacituzumab govitecan is currently being evaluated in the Phase 2 TROPHY U-01 study of patients with metastatic urothelial cancer. Interim results from 35 patients included in the 100 patient cohort of cisplatin-eligible patients who have relapsed or are refractory to PD-1 or PD-L1 inhibitor and platinum-based chemotherapy were presented at the 2019 European Society for Medical Oncology Annual Congress and showed an overall response rate of 29%, consistent with previously reported data in this population.

Read Immunomedics press release