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AstraZeneca PLC and Daiichi Sankyo Co Ltd on Monday said their drug conjugate Enhertu has been approved for more patients in the US.
It can now be used for patients ‘with unresectable or metastatic human epidermal growth factor receptor [HER2]-low breast cancer who have received a prior chemotherapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy,’ AstraZeneca explained.
Back in May, Cambridge-based AstraZeneca said the drug conjugate was approved for the treatment of unresectable or metastatic HER 2-positive breast cancer in the US.
At the time, Enhertu also had received breakthrough therapy designation for the treatment of patients with HER2-low breast cancer, and it was approved for this use on Monday.
‘Today's Food & Drug Administration approval marks a monumental moment in breast cancer treatment as Enhertu is the first-ever HER2-directed medicine to be approved for the treatment of patients with HER2-low metastatic breast cancer,’ said Ken Keller, global head of Oncology Business at Tokyo-based Daiichi Sankyo.
Enhertu, whose generic name is trastuzumab deruxtecan, is a specifically engineered HER2-directed antibody drug conjugate.
AstraZeneca shares were 0.7% lower at 10,790 pence each in London on Monday morning. Daiichi Sankyo shares closed up 5.2% at JP¥3,643 in Tokyo.
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