Fast track review for sacituzumab govitecan to treat mUCMay 9, 2020
Fast track designation has been granted for sacituzumab govitecan by USFDA for the treatment of adult patients with locally advanced or metastatic urothelial cancer (mUC).
The treatment is indicated for patients who have previously received a PD-1 or PD-L1 inhibitor, and a platinum containing chemotherapy in the neoadjuvant/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 neoadjuvant/adjuvant, locally advanced, or metastatic setting.
Sacituzumab govitecan is currently being evaluated in the phase 2 TROPHY U-01 study of patients with mUC. 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 showed an overall response rate of 29 percent, consistent with previously reported data in this population.