Gilead’s Trodelvy® (Sacituzumab Govitecan-hziy) Granted FDA Breakthrough Therapy Designation

On 17 December 2024, Gilead Sciences announced that the US FDA has granted Breakthrough Therapy Designation (BTD) to Trodelvy® (sacituzumab govitecan-hziy) for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) whose disease has progressed on or after platinum-based chemotherapy. 

Trodelvy® was previously approved in Australia for the treatment of unresectable locally advanced or metastatic triple-negative breast cancer (September 2021).