AstraZeneca, Daiichi Sankyo Get New EU Approval for Breast Cancer Drug
By Adria Calatayud
AstraZeneca and Daiichi Sankyo said they received European Union approval for a drug combination that includes their Enhertu medicine as a front-line treatment for a type of advanced breast cancer.
The drugmakers said Tuesday that the EU authorization for Enhertu in combination with Roche Holding's Perjeta followed a positive opinion from a European Medicines Agency committee. The approval was based on the results of a late-stage clinical trial that showed the combination reduced the risk of disease progression or death compared with the standard-of-care therapy, they added.
This marks the first new treatment regimen in the EU for a type of metastatic breast cancer known as HER2-positive in more than a decade, and the second new indication for Enhertu in the EU in two months, the companies said.
AstraZeneca separately said a late-stage trial in China evaluating its Tagrisso drug in combination with Orpathys--which the U.K. drugmaker is developing jointly with Hutchmed--showed an improvement in progression-free survival compared with Tagrisso alone for a type of lung cancer.
Write to Adria Calatayud at adria.calatayud@wsj.com
(END) Dow Jones Newswires
September 01, 2026 03:16 ET (07:16 GMT)
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