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Trodelvy Granted FDA Breakthrough Therapy Designation

A Phase 2 study showed encouraging results with Trodelvy as a second-line treatment for extensive-stage small cell lung cancer.

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By: Charlie Sternberg

Associate Editor

The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to Gilead Sciences Inc.’s Trodelvy (sacituzumab govitecan-hziy) 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. This is the second Breakthrough Therapy Designation for Trodelvy.   The Breakthrough Therapy Designation is based on results from the global Phase 2 TROPiCS-03 study ES-SCLC cohort, whi...

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