AstraZeneca's Etcamah receives FDA accelerated approval for breast cancer

The US Food and Drug Administration (FDA) has granted accelerated approval to AstraZeneca’s Etcamah (camizestrant) in combination with a CDK4/6 inhibitor (abemaciclib, palbociclib, or ribociclib). The therapy is intended for adults with hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer who develop an estrogen receptor 1 (ESR1) mutation during treatment with an aromatase inhibitor and a CDK4/6 inhibitor.

The approval is based on results from the Phase III SERENA-6 trial. A planned interim analysis indicated that the Etcamah combination reduced the risk of disease progression or death by 56% compared to standard treatment using an aromatase inhibitor plus a CDK4/6 inhibitor. Median progression-free survival was reported at 16.0 months for the Etcamah group versus 9.2 months for the control group.

As part of this approval, the FDA also cleared a companion diagnostic to detect emerging ESR1 resistance mutations in circulating tumor DNA (ctDNA). This allows clinicians to identify the mutation and adjust therapeutic strategies before significant disease progression occurs.