By Adria Calatayud


AstraZeneca got the backing of European Union drug regulators for the approval of an experimental breast-cancer drug, weeks after a U.S. Food and Drug Administration advisory panel voted against it.

The European Medicines Agency said Friday that its committee for medicinal products for human use issued a positive opinion for AstraZeneca's Etcamah--also known as camizestrant--for the treatment of a specific type of advanced breast cancer. The European Commission--the EU's executive arm--has the final say on granting marketing authorization for the drug.

The U.K. drugmaker separately said the EMA recommendation is for camizestrant in combination with another drug as a first-line treatment for a type of advanced or metastatic breast cancer.

Susan Galbraith, AstraZeneca's executive vice president of oncology and hematology research and development, called the decision a vote of confidence in the pivotal trial that was the basis for the company's application.

The recommendation from the EMA comes after the Food and Drug Administration's oncologic drugs advisory committee in late April voted against the benefit-risk profile of camizestrant. The FDA takes the committee's guidance into consideration, but isn't bound by it.

The EMA also recommended a label expansion for AstraZeneca and Daiichi Sankyo's Enhertu for approval in the EU for patients with previously treated metastatic solid tumors, the U.K. company said.

Separately, Datroway, another drug jointly developed by AstraZeneca and Daiichi Sankyo, was approved in the U.S. for the treatment of a different type of breast cancer, AstraZeneca said.


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


(END) Dow Jones Newswires

05-22-26 1057ET