Gilead Sciences Inc., (NASDAQ: GILD), a leading US-based biopharmaceutical company, has announced its intention to voluntarily withdraw the accelerated approval of its antibody-drug conjugate (ADC) Trodelvy (sacituzumab govitecan) for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC) who have been previously treated with platinum-based chemotherapy and a PD-1/PD-L1 inhibitor.
Trodelvy, a TROP-2-directed ADC, has been previously approved to treat triple negative breast cancer and HR+/HER2 metastatic breast cancer. The decision to withdraw the indication filing comes after the results of the confirmatory TROPiCS-04 study did not meet the primary endpoint of overall survival for the drug in the treatment of previously treated locally advanced or metastatic UC. Data presented in May this year indicated no survival benefit with sacituzumab govitecan compared to chemotherapy.
This development reflects Gilead’s commitment to the integrity of its clinical data and the rigorous standards required for maintaining drug approvals in the United States.- Flcube.com
