HER2-Targeting Antibody Drug Conjugate Gets Priority Review for Metastatic Breast Cancer

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.