AstraZeneca (AZN) and Daiichi Sankyo said their drug Enhertu has been approved in the US for the treatment of adult patients with certain types of inoperable breast cancer that has progressed on one or more endocrine therapies.
The drug, also known as fam-trastuzumab deruxtecan-nxki, has specifically been approved for use in patients with metastatic hormone receptor-positive, HER2-low, or HER2-ultralow types of breast cancer as determined by a US Food and Drug Administration-approved test, the companies said Monday.
The approval came after the drug secured Priority Review and Breakthrough Therapy Designation and was based on results from a phase 3 trial in which Enhertu showed a 36% reduction in the risk of disease progression or death in comparison with chemotherapy, the companies said.
The antibody drug conjugate was discovered by Daiichi Sankyo and is being jointly developed and commercialized by AstraZeneca and Daiichi Sankyo, the companies said.
免責聲明：投資有風險，本文並非投資建議，以上內容不應被視為任何金融產品的購買或出售要約、建議或邀請，作者或其他用戶的任何相關討論、評論或帖子也不應被視為此類內容。本文僅供一般參考，不考慮您的個人投資目標、財務狀況或需求。TTM對信息的準確性和完整性不承擔任何責任或保證，投資者應自行研究並在投資前尋求專業建議。