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AstraZeneca breast cancer drug candidate clears FDA hurdle

By Josh White

Date: Thursday 17 Oct 2019

AstraZeneca breast cancer drug candidate clears FDA hurdle

(Sharecast News) - AstraZeneca, alongside its partner Daiichi Sankyo Company, announced on Thursday that the US Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for trastuzumab deruxtecan, or DS-8201, and granted it 'Priority Review' status.
The FTSE 100 pharmaceuticals giant said the Prescription Drug User Fee Act date for trastuzumab deruxtecan - a HER2-targeting antibody drug conjugate and potential new medicine for the treatment of HER2-positive metastatic breast cancer - was set for the second quarter of 2020.

"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 AstraZeneca's executive vice-president of oncology research and development, José Baselga.

"This Priority Review draws on the strength and the consistency of results seen in the phase 1 and phase 2 trials and is a critical step on the journey to deliver this potential new medicine to patients."

Antoine Yver, executive vice-president and global head of oncology research and development at Daiichi Sankyo Company, added that the firm was "pleased" that the FDA had accepted the application and granted Priority Review, as it believed trastuzumab deruxtecan had 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," Yver said.

Trastuzumab deruxtecan was previously granted US FDA 'Breakthrough Therapy' and 'Fast Track' designation.

The Biologics License Application was based on the combination of data from the phase 1 trial published in The Lancet Oncology, and the pivotal phase 2 'DESTINY-Breast01' trial.

AstraZeneca said 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 was set to be presented at the upcoming San Antonio Breast Cancer Symposium in December.

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