Gilead Sciences earns USFDA Breakthrough Therapy Designation for lung cancer treatment Trodelvy
Foster City: Gilead Sciences, Inc. has announced that Trodelvy (sacituzumab govitecan-hziy) has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) 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.
The Breakthrough Therapy Designation is based on results from the global Phase 2 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.
Lung cancer is the second most diagnosed cancer in the U.S., and the leading cause of cancer-related deaths. Approximately 15% of lung cancer cases are SCLC, with nearly 70% of patients with SCLC diagnosed at extensive-stage, which occurs when the cancer has spread to both lungs or beyond the lungs to lymph nodes or other organs. For people with ES-SCLC whose disease does not respond to current first-line standard of care (platinum-based chemotherapy or immunotherapy), the prognosis is often poor, and treatment options are limited. There is an urgent need for new and more effective approaches to care that can improve survival and slow the progression of the disease.
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