FDA grants Breakthrough status to Trodelvy for SCLC
Gilead Sciences. Inc. announced that the FDA has granted Breakthrough Therapy Designation 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
This Designation is based on results from the global Phase II TROPiCS-03 study ES-SCLC cohort, which showed encouraging results with Trodelvy as a second-line treatment for ES-SCLC. As recently presented at the IASLC 2024 World Conference on Lung Cancer, Trodelvy demonstrated promising antitumor activity in both platinum-resistant (PR) and platinum-sensitive (PS) disease and the safety profile was consistent with previous Trodelvy studies. These data support further investigation of Trodelvy in ES-SCLC and Gilead plans to initiate a Phase III clinical trial in this patient population.
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.
6 mins