AstraZeneca, Daiichi Sankyo Drug Gets U.S. Nod for Breast-Cancer Label Expansion

By Adria Calatayud

AstraZeneca and Daiichi Sankyo got U.S. approval to expand the label of their jointly developed Enhertu drug in combination with another medicine as an initial treatment for a type of breast cancer.

The companies said late Monday that the move will trigger a payment of $150 million from AstraZeneca to Daiichi Sankyo as part of a collaboration deal they reached in 2019.

The approval for Enhertu in combination with Roche Holding's Perjeta is for the first-line treatment of adult patients of a form of breast cancer known as HER2-positive for which the tumor can't be removed or in which the disease has spread to other parts of the body, the companies said.

Enhertu was first approved six years ago and has moved to earlier phases of treatment. This will be the first new initial treatment for this type of breast cancer approved in the U.S. in a decade, the companies said.

The decision was based on the results of late-stage clinical trial that showed the drug combination reduced the risk of disease progression and followed FDA designations of priority review and breakthrough therapy, AstraZeneca and Daiichi Sankyo said.

Separate regulatory applications are under review in other countries, the companies added.

Write to Adria Calatayud at adria.calatayud@wsj.com

(END) Dow Jones Newswires

December 16, 2025 02:31 ET (07:31 GMT)