Cecilia Brown

Lung Cancers Today

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 <a href="https://www.docwirenews.com/post/second-line-sacituzumab-govitecan-shows-promising-efficacy-in-extensive-stage-sclc" target="_blank" rel="noopener">recently presented</a> at the <a href="https://www.docwirenews.com/conference/iaslc-2024-world-conference-on-lung-cancer" target="_blank" rel="noopener">IASLC 2024 World Conference on Lung Cancer</a>, 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: <a href="https://www.gilead.com/news/news-details/2024/us-fda-grants-breakthrough-therapy-designation-to-trodelvy-sacituzumab-govitecan-hziy-for-second-line-treatment-of-extensive-stage-small-cell-lung-cancer" target="_blank" rel="noopener">Gilead Sciences, Inc.</a>

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FDA Grants Breakthrough Therapy Designation to Sacituzumab Govitecan for Second-Line Treatment of ES-SCLC

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The US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to sacituzumab govitecan-hziy (Trodelvy®) for extensive-stage small cell lung cancer.

FDA Grants Breakthrough Therapy Designation to Sacituzumab Govitecan for ES-SCLC