FDA approves new treatment for patients with advanced breast cancer
AstraZeneca's Etcamah (camizestrant) has received accelerated FDA approval for treating advanced breast cancer with ESR1 mutations, in combination with CDK4/6 inhibitors, based on its ability to delay disease progression.
AstraZeneca recently received accelerated approval from the U.S. Food and Drug Administration for a new treatment option for patients with advanced breast cancer.
The medication, Etcamah (camizestrant), was approved to be used in combination with a CDK4/6 inhibitor to treat adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer upon detection of estrogen receptor-1 (ESR1) mutation during aromatase inhibitor and CDK 4/6 inhibitor therapy, based on an FDA-authorized test, according to the FDA. The agency authorized the Guardant360 CDx assay for this detection.
The FDA granted accelerated approval based on the drug’s ability to slow disease progression. Specifically, researchers measured that median progression-free survival in patients taking Etcamah with a CDK4/6 inhibitor after the ESR1 mutation was originally detected was 16 months. The FDA is requiring additional studies to validate these results and their clinical benefit.
