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AstraZeneca PLC on Tuesday said a breast cancer drug developed with Tokyo-based partner Daiichi Sankyo Co Ltd has been approved in the European Union.
The Cambridge, England-based pharmaceutical company's Enhertu is aimed at treating those with unresectable or metastatic HER2-positive breast cancer, who have received one or more prior anti-HER2-based regimens.
HER-2 is a growth promoting protein. Unresectable tumours cannot be removed with surgery, while metastatic refers to cancer that spreads from where it started to another part of the body.
In the DESTINY-Breast03 Phase III trial, Enhertu reduced the risk of disease progression or death by 72% compared to trastuzumab emtansine. Trastuzumab emtansine is a type of targeted cancer drug for early breast cancer or breast cancer that has spread or come back within six months of finishing treatment.
AstraZeneca Executive Vice President Dave Fredrickson 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.’
More than 530,000 patients are diagnosed with breast cancer each year, and about one in five patients are considered HER2-positive.
Following the approval by the European Commision, AstraZeneca will pay $75 million to Daiichi Sankyo as a ‘milestone payment in 2nd-line HER2-positive metastatic breast cancer,’ the company noted.
In March 2019, Daiichi Sankyo and AstraZeneca signed a deal to develop and commercialise Enhertu.
Shares were down 0.6% at 11,033.00 pence each on Tuesday morning in London. Sankyo shares closed 2.9% lower at JP¥3,508 each in Tokyo.
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