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FDA Grants Trastuzumab Deruxtecan Priority Review for HER2+ Breast Cancer

Jason M. Broderick @jasoncology
Published: Thursday, Oct 17, 2019

Jose Baselga, MD, PhD, executive vice president, Oncology R&D, AstraZenec

José Baselga, MD, PhD

The FDA has granted a priority review designation to a biologics license application (BLA) for [fam-] trastuzumab deruxtecan (DS-8201) for the treatment of patients with HER2-positive metastatic breast cancer.1

“We are pleased that the FDA has accepted the application and granted priority review, as we believe trastuzumab deruxtecan has the potential to redefine the treatment of patients with HER2-positive metastatic breast cancer. Following the recent regulatory submission in Japan, we look forward to working closely with regulatory authorities to bring trastuzumab deruxtecan to patients in the US and Japan as soon as possible,” Antoine Yver, MD, MSc, executive vice president and global head, Oncology Research and Development, Daiichi Sankyo, said in the press release.


  1. Trastuzumab deruxtecan granted FDA Priority Review for treatment of patients with HER2-positive metastatic breast cancer. AstraZeneca. Published October 17, 2019. Accessed October 17, 2019.
  2. Tamura K, Tsurutani J, Takahashi S, et al. Trastuzumab deruxtecan (DS-8201a) in patients with advanced HER2-positive breast cancer previously treated with trastuzumab emtansine: a dose-expansion, phase 1 study. Lancet Oncol. 2019 Jun;20(6):816-826. doi: 10.1016/S1470-2045(19)30097-X.
  3. Trastuzumab deruxtecan demonstrated clinically-meaningful response in patients with refractory HER2-Positive Metastatic breast cancer, a population with high unmet need. AstraZeneca. Published May 8, 2019. Accessed October 17, 2019.

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