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Enhertu Goes Into High Gear With HER2-Low Breast Cancer Approval

 
• By Joseph Haas

AstraZeneca and partner Daiichi Sankyo obtain the first approval for targeted therapy in HER2-low metastatic breast cancer for Enhertu, about four months ahead of the FDA action date.

FDA Approved
Enhertu use in HER2-low breast cancer may take off with FDA nod

The US Food & Drug Administration’s approval of AstraZeneca PLC and Daiichi Sankyo Co., Ltd.’s antibody-drug conjugate Enhertu for HER2-low metastatic breast cancer is the culmination of months of anticipation and a key milestone in the firms’ goal to expand Enhertu’s reach, but AstraZeneca noted during its recent second quarter earnings report that the success the drug is seeing so far does not yet reflect use in the new indication.

The FDA cleared Enhertu for HER2-low metastatic breast cancer on 5 August, approximately four months ahead of the FDA action...

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