FDA Breakthrough status for Trodelvy in ES-SCLC

The US Food and Drug Administration (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, said Gilead Sciences (Nasdaq: GILD).

Sales of Trodelvy in its currently approved indications reached $1.1 billion in 2023, a 56% increase on the previous year. However, despite strong sales in breast cancer, it has disappointed in advanced or metastatic urothelial cancer, leading the company to withdraw its US accelerated approval indication. 

The Breakthrough Therapy 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 3 clinical trial in this patient population.