AstraZeneca's HER2-positive breast cancer drug receives EU approval
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Drugmaker AstraZeneca's Enhertu has received European Union approval to be used as a monotherapy for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer.
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AstraZeneca said on Tuesday that approval by the European Commission followed "ground-breaking" results from the DESTINY-Breast03 trial, in which Enhertu demonstrated a 72% reduction in the risk of disease progression or death versus trastuzumab emtansine.
The FTSE 100-listed group highlighted that Enhertu was "a specifically engineered HER2-directed antibody drug conjugate" that was being jointly developed and commercialised by itself and Japanese pharmaceutical company Daiichi Sankyo.
Dave Fredrickson, vice president of AstraZeneca's oncology unit, said: "With this approval, patients across Europe with HER2-positive metastatic breast cancer will have the opportunity to be treated with Enhertu even earlier in the treatment of their disease, improving their chance for better outcomes beyond what we can already offer patients treated in later-line settings.
"Today's news is a further step in achieving our vision to continuously bring the transformative potential of Enhertu to patients as early as possible in their treatment to improve cancer outcomes."
Reporting by Iain Gilbert at Sharecast.com