▎WuXiEdited by Kant Content Team
Gilead Sciences recently announced,The U.S. FDA has granted Trodelvy (sacituzumab govitecan) Breakthrough Therapy Designation for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) whose disease has progressed after platinum-based chemotherapy.The press release noted that this is the second Breakthrough Therapy Designation received by Trodelvy.
This breakthrough therapy designation is based on the results of the ES-SCLC cohort in the global Phase 2 clinical trial TROPiCS-03, which showed encouraging effects of Trodelvy as a second-line treatment for ES-SCLC. The relevant data were presented at the 2024 International Association for the Study of Lung Cancer (IASLC) World Conference on Lung Cancer. The study demonstrated,Trodelvy Demonstrates Promising Antitumor Activity in Both Platinum-Resistant (PR) and Platinum-Sensitive (PS) Diseases, its safety profile was consistent with previous Trodelvy study results. These data support further research on Trodelvy in ES-SCLC, and Gilead plans to initiate a Phase 3 clinical trial in this patient population.Small cell lung cancer accounts for approximately 15% of lung cancer cases, with about 70% of patients being in the extensive stage at diagnosis, meaning the cancer has spread to both lungs, lymph nodes outside the lungs, or other organs. For patients with ES-SCLC, when the disease does not respond to current first-line standard treatments (platinum-based chemotherapy or immunotherapy), the prognosis is generally poor and treatment options are limited.Trodelvy is the first approved antibody-drug conjugate (ADC) targeting Trop-2, demonstrating significant survival benefits in two different types of metastatic breast cancer.Trop-2 is a cell surface antigen that is highly expressed in various tumor types, including over 90% of breast and lung cancers. Trodelvy combines a proprietary hydrolysable linker with the topoisomerase I inhibitor SN-38 payload. This unique combination exhibits potent activity against Trop-2 expressing cells and the tumor microenvironment through a bystander effect.Currently, Trodelvy has been approved in more than 50 countries and regions for the treatment of previously treated metastatic triple-negative breast cancer (TNBC) patients; and in more than 40 countries and regions for certain previously treated HR+/HER2- metastatic breast cancer patients.
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References:
[1] U.S. FDA Grants Breakthrough Therapy Designation to Trodelvy® (sacituzumab govitecan-hziy) for Second-Line Treatment of Extensive-Stage Small Cell Lung Cancer. Retrieved December 18, 2024, from https://www.businesswire.com/news/home/20241216528668/en
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