17 October 2019 - Daiichi Sankyo and AstraZeneca today announced that the U.S. FDA has accepted for review the biologics license application for trastuzumab deruxtecan (DS-8201) and granted priority review.
The Prescription Drug User Fee Act date for trastuzumab deruxtecan, an investigational HER2 targeting antibody drug conjugate for the treatment of patients with HER2 positive metastatic breast cancer is set for the first quarter of fiscal year 2020.
Trastuzumab deruxtecan was previously granted U.S. FDA breakthrough therapy designation and fast track designation. The application is based on the combination of data from the phase 1 trial published in The Lancet Oncology, and the pivotal phase 2 DESTINY-Breast01 trial.