HER2-positive metastatic breast cancer treatment granted Priority Review

The US Food and Drug Administration (FDA) has accepted a Biologics License Application (BLA) for review and granted Priority Review for [fam-] trastuzumab deruxtecan (DS-8201), a HER2-targeting antibody drug conjugate (ADC) and potential new medicine for the treatment of HER2-positive metastatic breast cancer.

The Prescription Drug User Fee Act (PDUFA) date for the treatment is set for the second quarter of 2020, AstraZeneca and Daiichi Sankyo Company Ltd, which produce the drug, have announced.

“[Fam-] trastuzumab deruxtecan has the potential to transform the treatment landscape for patients with HER2-positive metastatic breast cancer who have limited treatment options today,” said José Baselga, Executive Vice President, Oncology R&D, AstraZeneca. “This Priority Review draws on the strength and the consistency of results seen in the Phase I and Phase II trials and is a critical step on the journey to deliver this potential new medicine to patients.”

The BLA is based on the combination of data from the Phase I trial and the pivotal Phase II DESTINY-Breast01 trial. The response rate observed in DESTINY-Breast01, as assessed by an independent review committee, validated the results observed in the Phase I trial.

“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,” added Antoine Yver, 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 US and Japan as soon as possible.”