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(Alliance News) - FTSE 100-listed drugmaker AstraZeneca PLC said Thursday US regulators granted its trastuzumab deruxtecan breast cancer drug priority review following strong clinical trial results.
AstraZeneca and development partner Daiichi Sankyo Co Ltd said the US Food & Drug Administration accepted the biologics license application for trastuzumab deruxtecan for review as well as granting it priority review.
The application is for the use of the HER2-targeting antibody drug to treat HER2-positive metastatic breast cancer. The review is expected 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," AstraZeneca Oncology Research & Development Vice President Jose Baselga said.
"This priority review draws on the strength and the consistency of results seen in the phase one and phase two trials and is a critical step on the journey to deliver this potential new medicine to patients," Baselga added.
Shares in AstraZeneca were 0.4% higher at 6,841.00 pence in London on Thursday.
By Ahren Lester; ahrenlester@alliancenews.com
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