FDA official announcements and press releases

FDA Grants Breakthrough Therapy Designation to Trodelvy for ES-SCLC Treatment

Dec 18, 2024, 12:06 PM

The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to Trodelvy® (sacituzumab govitecan-hziy) for the second-line treatment of extensive-stage small cell lung cancer (ES-SCLC). This designation is intended to expedite the development and review of drugs that demonstrate substantial improvement over existing therapies for serious or life-threatening conditions. Trodelvy, developed by Gilead Sciences, has shown promise in addressing the needs of patients with ES-SCLC who have limited treatment options. The FDA's decision highlights the potential of Trodelvy to improve outcomes for this patient population.