AstraZeneca breast cancer drug receives EU approval

(Sharecast News) - A breast cancer drug developed by AstraZeneca has been approved in the European Union for the treatment of certain types of the disease, the pharmaceutical giant announced on Thursday. Used in combination with a CDK4/6 inhibitor, Etcamah has been approved by Brussels for the treatment of adults with oestrogen receptor (ER) positive, HER2-negative locally advanced or metastatic breast cancer, upon detection of ESR1 mutation and without disease progression during first-line endocrine therapy.

The green light was based on positive results from the Serena-6 phase III trial. An interim analysis showed the Etcamah combination reduced the risk of disease progression or death by 56% when compared to the standard-of-care treatment, of an aromatase inhibitor in combination with CDK4/6.

Dave Fredrickson, executive vice president of AstraZeneca's oncology haematology business unit, said the approval "marks an important shift in the first-line treatment paradigm" for patients, as well as providing a new standard-of-care "to address emerging resistance ahead of disease progression".

He continued: "It also reflects the strength of AstraZeneca's oncology pipeline and our commitment to translate innovative science into practice-changing treatment options for patients."

Breast cancer remains the leading cause of cancer death among women in Europe, with more than 140,000 deaths and 540,000 diagnoses in 2024. Hormone receptor (HR)-positive breast cancer is the most common subtype, with 70% of tumours considered HR-positive and HER-negative. More than 97% of HR-positive tumours are ER-positive.

As at 1230 BST, the stock was trading 1% lower at 12,568p.

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