Trastuzumab Deruxtecan (DS-8201) Granted FDA Priority Review for Treatment of Patients with HER2 Positive Metastatic Breast Cancer

Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) and AstraZeneca today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for [fam-] trastuzumab deruxtecan (DS-8201) and granted Priority Review.

The Prescription Drug User Fee Act (PDUFA) date for [fam-] trastuzumab deruxtecan, an investigational HER2 targeting antibody drug conjugate (ADC), for the treatment of patients with HER2 positive metastatic breast cancer is set for the first quarter of fiscal year 2020.

“We are pleased that the FDA has accepted the application and granted Priority Review as we believe [fam-] trastuzumab deruxtecan has the potential to redefine the treatment of patients with HER2 positive metastatic breast cancer,” said Antoine Yver, MD, MSc, Executive Vice President and Global Head, Oncology Research and Development, Daiichi Sankyo. “Following the recent regulatory submission in Japan, we look forward to working closely with regulatory authorities to bring [fam-] trastuzumab deruxtecan to patients in the U.S. and Japan as soon as possible.”

“[Fam-] trastuzumab deruxtecan has the potential to transform the treatment landscape for patients with HER2 positive metastatic breast cancer who have limited treatment options,” said José Baselga, MD, PhD, Executive Vice President, Research & Development Oncology, AstraZeneca. “The priority review draws on the strength and consistency of results seen in phase 1 and phase 2 trials and is an important step on the journey to deliver this potential new medicine to patients.”

[Fam-] trastuzumab deruxtecan was previously granted U.S. FDA Breakthrough Therapy Designation and Fast Track designation. The BLA is based on the combination of data from the phase 1 trial published in The Lancet Oncology,1 and the pivotal phase 2 DESTINY-Breast01 trial. The response rate observed in DESTINY-Breast01, as assessed by an independent review committee, validated the clinical activity observed in the phase 1 trial. Detailed data from DESTINY-Breast01 will be presented at the forthcoming San Antonio Breast Cancer Symposium in December.

Source:https://www.businesswire.com/news/home/20191017005303/en/Fam--Trastuzumab-Deruxtecan-DS-8201-Granted-FDA-Priority

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