AstraZeneca (NASDAQ: AZN) announced that the European Medicines Agency's Committee for Medicinal Products for Human Use recommended approval of camizestrant in combination with CDK4/6 inhibitors for treating specific breast cancer patients.

The recommendation covers adult patients with estrogen receptor-positive, HER2-negative locally advanced or metastatic breast cancer who develop ESR1 mutations during first-line endocrine therapy combined with CDK4/6 inhibitors, according to the company's statement.

The recommendation was based on results from the SERENA-6 Phase III trial. In a planned interim analysis, the camizestrant combination reduced the risk of disease progression or death by 56% compared to standard treatment with aromatase inhibitors combined with CDK4/6 inhibitors. The median progression-free survival was 16.0 months versus 9.2 months for standard treatment.

SERENA-6 represents the first global Phase III trial to use circulating tumor DNA monitoring to detect endocrine resistance and guide therapy changes before disease progression occurs. The trial monitored patients through blood tests every two to three months to identify ESR1 mutations.

The drug combination is currently approved in the United Arab Emirates and Saudi Arabia for hormone receptor-positive, HER2-negative advanced breast cancer patients with emergent ESR1 mutations. Regulatory applications are under review in the United States, Japan and other countries.

The safety profile of camizestrant combined with CDK4/6 inhibitors was consistent with known safety profiles of each medicine, with no new safety concerns identified and low discontinuation rates similar to both treatment arms.