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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, Contract Pharma

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, which showed encouraging results with Trodelvy as a second-line treatment for ES-SCLC. 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.
 
Trodelvy is the first and only approved Trop-2-directed antibody-drug conjugate (ADC) that has demonstrated meaningful survival advantages in two different types of metastatic breast cancers. Across Phase 3 trials, we are exploring Trodelvy alone or in combination with other agents across many diverse tumor types and stages of disease. This includes collaborations with partners in academia, industry and the global cancer community.

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