The Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) and granted Priority Review to an investigational treatment for HER2-positive metastatic breast cancer.
[Fam-] trastuzumab deruxtecan (DS-8201a) is a HER2-targeting antibody drug conjugate that is being jointly developed by AstraZeneca and Daiichi Sankyo; antibody drug conjugates deliver cytotoxic agents to cancer cells via a linker attached to a monoclonal antibody that binds to a specific target expressed on cancer cells.The treatment previously earned Breakthrough Therapy Designation and Fast Track designation from the Agency.
The BLA includes data from a phase 1 dose-expansion trial and a phase 2 interventional study. The phase 2 trial is evaluating the safety and efficacy of trastuzumab deruxtecan in 230 patients with HER2-positive unresectable and/or metastatic breast cancer previously treated with trastuzumab emtansine. Top-line data announced in May 2019 showed that the trial met its primary end point, demonstrating a clinically meaningful response with trastuzumab deruxtecan. Detailed data from the trial will be released at a Breast Cancer Symposium in December.
The Agency has set a Prescription Drug User Fee Act (PDUFA) date for the second quarter of 2020.
For more information visit Astrazeneca.com.