
The US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to sacituzumab govitecan-hziy (Trodelvy®) for the treatment of adults with extensive-stage small cell lung cancer (ES-SCLC) whose disease has progressed on or after platinum-based chemotherapy, according to an announcement from Gilead Sciences, Inc.
The Breakthrough Therapy Designation is based on results from the ES-SCLC cohort in the global phase 2 TROPiCS-03 study, “which showed encouraging results with Trodelvy® as a second-line treatment for ES-SCLC,” Gilead officials said in the announcement.
“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,” company officials said. “These data support further investigation of [Trodelvy®] in ES-SCLC and Gilead plans to initiate a phase 3 clinical trial in this patient population.”
This marks the second Breakthrough Therapy Designation for sacituzumab govitecan-hziy, which is the “first and only approved Trop-2-directed antibody-drug conjugate that has demolnstrated meaningful survival advantages in two different types of metastatic breast cancers.”
Source: Gilead Sciences, Inc.