Conjugate for the treatment of metastatic urothelial cancer
The company has approved the fast track drug based on data from the TROPHY Phase 2 trial. It has shown that 27.7% of 112 patients responded to Trodelvy, 5.4% – a complete response and 22.3% – a partial response.
Trodelvy (sakituzumab govitecan) can be used to treat metastatic or locally advanced urothelial cancer after prior platinum-containing chemotherapy and immunotherapy with checkpoint inhibitor PD-1/PD-L1. To maintain this indication for the drug, the FDA will require long-term survival data. The company also expects its conjugate to be used in those who have not responded to immunotherapy treatment (Bavencio - Pfiser's avelumab), which is given after the initial course of chemotherapy. Gilead said that the drug has the risk of side effects in the form of severe or life-threatening neutropenia and severe diarrhea. In 10% of patients treated with Trodelvy, the adverse reactions that led to discontinuation of treatment were reported.
Source: PHARMA PHORUM