28th Jan 2025 07:00
(Alliance News) - AstraZeneca PLC and Daiichi Sankyo Co Ltd on Monday celebrated another approval of their cancer drug Enhertu.
The Cambridge, England-based and Tokyo-based pharmaceutical companies said the US Food & Drug Administration approved Enhertu for the treatment of adult patients with unresectable or metastatic hormone receptor-positive, HER2-low, IHC 1+ or IHC 2+/ISH-, or HER2-ultralow, IHC 0, with membrane staining, breast cancer.
The approval is based on phase 3 trial results which were presented in 2024 at the American Society of Clinical Oncology.
In the trial, Enhertu showed a 36% reduction in the risk of disease progression or death, compared to chemotherapy, in the overall trial population of patients with chemotherapy-naïve HER2-low or HER2-ultralow metastatic breast cancer.
Dave Fredrickson, executive vice president of the Oncology Haematology Business Unit at AstraZeneca, said: "Building on the practice-changing previous approvals for Enhertu, this new approval brings this important medicine to an earlier treatment setting and a broader patient population with HER2-expressing metastatic breast cancer. The approval also highlights the importance of testing metastatic breast cancer tumours for detectable staining with a standard IHC test to identify those who may be eligible for treatment with Enhertu following endocrine therapy."
Ken Keller, global head of Daiichi's Oncology Business, said: "Enhertu continues to redefine the classification and treatment of HR-positive metastatic breast cancer with important new data across the spectrum of HER2 expression. Today's approval underscores our ongoing commitment to realising the full potential of this innovative antibody drug conjugate and represents another paradigm shift in how certain breast cancers can be treated."
AstraZeneca shares closed 1.1% higher at 11,170.00 pence on Monday in London, prior to the announcement. Daiichi shares closed 1.5% higher at JPY4,452.00 on Tuesday in Tokyo.
By Tom Budszus, Alliance News slot editor
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