FDA official announcements and press releases

FDA Grants Breakthrough Therapy Designation to Trodelvy for Advanced NSCLC and Extensive-Stage Small Cell Lung Cancer

Dec 17, 2024, 01:36 PM

The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to sacituzumab tirumotecan, also known as Trodelvy, for the treatment of advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) with EGFR mutations that have progressed after treatment with a tyrosine kinase inhibitor (TKI) and chemotherapy. This designation is significant for Gilead Sciences, as it enhances the potential for expedited development and review of the therapy. Additionally, the FDA has also recognized Trodelvy for use as a second-line treatment for extensive-stage small cell lung cancer, marking another important milestone for the drug's application in oncology.