FDA Grants Priority Review for Trastuzumab Deruxtecan in Metastatic Breast Cancer
Posted: Monday, October 28, 2019
On October 17, AstraZeneca and Daiichi Sankyo Company, Limited announced that the U.S. Food and Drug Administration (FDA) has accepted for review the biologics license application for [fam-] trastuzumab deruxtecan (DS-8201) and granted Priority Review. The Prescription Drug User Fee Act date for trastuzumab deruxtecan, a HER2-targeting antibody-drug conjugate and potential new treatment of HER2-positive metastatic breast cancer, is set for the second quarter of 2020.
Trastuzumab deruxtecan was previously granted FDA Breakthrough Therapy designation and Fast Track designation. The biologics license application is based on the combination of data from the phase I trial published in The Lancet Oncology and the pivotal phase II DESTINY-Breast01 trial, which evaluated this agent’s safety and efficacy in patients with HER2-positive unresectable and/or metastatic breast cancer previously treated with trastuzumab emtansine (T-DM1). The response rate observed in DESTINY-Breast01, as assessed by an independent review committee, validated the clinical activity observed in the phase I trial. Detailed data from DESTINY-Breast01 will be presented at the upcoming San Antonio Breast Cancer Symposium in December.