FDA Approves Trastuzumab Deruxtecan for HER2+ Breast Cancer

December 20, 2019 – The FDA has granted an accelerated approval to fam-trastuzumab deruxtecan-nxki (DS-8201) for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received ≥2 prior anti–HER2-based regimens in the metastatic setting. The approval is based on findings from the phase II DESTINY-Breast01 trial, updated data of which were presented at the 2019 San Antonio Breast Cancer Symposium. In the … (leggi tutto)