AstraZeneca drug approved for breast cancer in EU

AstraZeneca’s breast cancer drug Etcamah has been approved in the EU as part of a combination treatment for advanced disease.

The European Commission acted on a positive opinion from the Committee for Medicinal Products for Human Use, the Cambridge, England-based drug maker said.

The decision followed positive results from the Serena-6 phase III trial, which showed a 56 per cent reduction in the risk of disease progression in advanced oestrogen receptor-positive breast cancer.

A phase III trial is a large, late-stage study used to assess a treatment’s safety and effectiveness before wider regulatory approval.

Oestrogen receptor-positive breast cancer is a form of the disease that can grow in response to the hormone oestrogen.

Etcamah, whose generic name is camizestrant, was tested in combination with a cyclin-dependent kinase 4/6 inhibitor.

Known as CDK4/6 inhibitors, these medicines block proteins that help cancer cells grow and divide.

AstraZeneca said the Etcamah combination has also been approved in Japan, the UAE and Saudi Arabia based on the Serena-6 trial results.

The company said breast cancer remains the leading cause of cancer death among women in Europe, with more than 140,000 deaths and more than 540,000 patients diagnosed in 2024.

AstraZeneca shares were down 0.6 per cent at 12,628 pence in London on Thursday.