AstraZeneca's Camizestrant Recommended for EU Approval in Advanced Breast Cancer
The European Medicines Agency's expert committee recommended camizestrant in combination with a CDK4/6 inhibitor for first-line advanced ER-positive breast cancer. The recommendation follows positive results from the SERENA-6 Phase III trial.
AstraZeneca announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended camizestrant for approval in the European Union. The drug would be used in combination with a cyclin-dependent kinase (CDK) 4/6 inhibitor to treat adult patients with estrogen receptor (ER)-positive, HER2-negative locally advanced or metastatic breast cancer.
The CHMP's positive opinion is based on findings from the pivotal SERENA-6 Phase III trial. In the trial, the combination of camizestrant with a CDK4/6 inhibitor (palbociclib, ribociclib, or abemaciclib) demonstrated a 56% reduction in the risk of disease progression or death compared to standard of care with an aromatase inhibitor and a CDK4/6 inhibitor. Median progression-free survival (PFS) was 16.0 months for the camizestrant combination versus 9.2 months for the standard arm.
Professor François-Clément Bidard, a principal investigator for the SERENA-6 trial, stated that the recommendation represents an important step forward for patients with advanced breast cancer in Europe and a milestone in adopting new treatment strategies. He highlighted the need for new treatments that delay disease progression in the first-line setting.
Susan Galbraith, Executive Vice President, Oncology Haematology R&D at AstraZeneca, described the CHMP's decision as a "vote of confidence" in the SERENA-6 trial. She noted it as the first pivotal trial to demonstrate the clinical value of monitoring circulating tumor DNA (ctDNA) to detect endocrine resistance and guide a change in therapeutic strategy in the first-line setting.
The safety profile of camizestrant in combination with CDK4/6 inhibitors in the SERENA-6 trial was consistent with the known profiles of the individual medicines. No new safety concerns were identified. The camizestrant combination is already approved in the UAE and Saudi Arabia, with regulatory applications under review in the US, Japan, and other countries.