Daiichi Sankyo Confirms Plans to Accelerate BLA Submission to U.S. FDA for [Fam-] Trastuzumab Deruxtecan (DS-8201) in HER2 Positive Metastatic Breast Cancer Post T-DM1

- BLA submission to U.S. FDA for [fam-] trastuzumab deruxtecan in HER2 positive metastatic breast cancer previously treated with T-DM1 to be accelerated to first half of fiscal year 2019

- Data from pivotal phase 2 DESTINY-Breast01 study, which will be presented at upcoming medical meeting, to form basis of BLA submission

- [Fam-] trastuzumab deruxtecan has been granted U.S. FDA Breakthrough Therapy designation for the treatment of patients with HER2 positive, locally advanced or metastatic breast cancer who have been treated with trastuzumab and pertuzumab and have disease progression after T-DM1

TOKYO and MUNICH and BASKING RIDGE, New Jersey, March 28, 2019 /PRNewswire/ -- Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced plans to accelerate filing of the Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) for [fam-] trastuzumab deruxtecan (DS-8201), an investigational HER2 targeting antibody drug conjugate (ADC), in patients with HER2 positive metastatic breast cancer previously treated with ado trastuzumab emtansine (T-DM1). Submission of the application, which was originally planned for 2020, is now scheduled for the first half of fiscal year 2019.

"We are pleased to confirm the acceleration of the [fam-] trastuzumab deruxtecan clinical development program for this potential indication in patients with HER2 positive metastatic breast cancer pretreated with T-DM1 ahead of schedule," said Antoine Yver, MD, MSc, Executive Vice President and Global Head, Oncology Research and Development, Daiichi Sankyo. "Simultaneously, we are committed to our aggressive development strategy evaluating the potential of [fam-] trastuzumab deruxtecan across a spectrum of HER2 expressing cancers including breast, gastric, lung and colorectal."

[Fam-] trastuzumab deruxtecan has been granted U.S. FDA Breakthrough Therapy for the treatment of patients with HER2 positive, locally advanced or metastatic breast cancer who have been treated with trastuzumab and pertuzumab and have disease progression after T-DM1. The initial BLA submission of [fam-] trastuzumab deruxtecan will be based on results from the pivotal phase 2 DESTINY-Breast01 study, which will be presented at an upcoming medical conference. Final determination of exact timing of the BLA submission of [fam-] trastuzumab deruxtecan will be based on the outcome of a pre-BLA meeting with the FDA.