FDA Grants Trastuzumab Deruxtecan Priority Review for HER2+ Breast Cancer

October 17, 2019 – The FDA has granted a priority review designation to a biologics license application (BLA) for [fam-] trastuzumab deruxtecan (DS-8201) for the treatment of patients with HER2-positive metastatic breast cancer. The BLA is supported by data from a phase I trial2 and the pivotal phase II DESTINY-Breast01 trial. Under the Prescription Drug User Fee Act, the action date for the BLA is in the second quarter of 2020, according to AstraZeneca and Daiichi … (leggi tutto)