Gilead's Trodelvy® Receives Breakthrough Therapy Designation for Extensive-Stage Small Cell Lung Cancer
Gilead Sciences has announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for Trodelvy® (sacituzumab govitecan-hziy) in the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) whose disease has progressed after platinum-based chemotherapy.
This designation follows encouraging results from the Phase 2 TROPiCS-03 study, which showed Trodelvy's effectiveness as a second-line treatment for ES-SCLC. The results, presented at the IASLC 2024 World Conference on Lung Cancer, highlighted promising antitumor activity in both platinum-resistant and platinum-sensitive disease, with a safety profile consistent with previous studies. A Phase 3 clinical trial is planned to further explore Trodelvy in this patient group.
Lung cancer is the second most common cancer in the U.S. and the leading cause of cancer-related deaths. Small cell lung cancer accounts for 15% of all lung cancer cases, with nearly 70% diagnosed at the extensive stage. Current treatment options for patients whose disease does not respond to chemotherapy are limited, highlighting the need for new therapies.
Trodelvy is the first Trop-2-directed antibody-drug conjugate (ADC) approved for metastatic breast cancer, offering survival benefits. It is being investigated for use in several cancers, including small cell lung cancer, where it has shown clinical promise in earlier studies.
Trodelvy is currently approved in over 50 countries for treating metastatic triple-negative breast cancer (TNBC) and in more than 40 countries for certain cases of HR+/HER2- metastatic breast cancer. Ongoing studies are examining its use in additional cancer types, such as head and neck and gynecological cancers.
The FDA has highlighted Trodelvy's potential to significantly improve outcomes for patients with serious cancers, expediting its development through the Breakthrough Therapy Designation. This marks the second time Trodelvy has received such recognition.
