The FDA has granted accelerated approval to Etcamah (camizestrant), marking the first FDA approval of a cancer therapy guided by the detection of a resistance mutation in circulating tumor DNA before imaging tests show disease progression.
Etcamah is used with a CDK4/6 inhibitor to treat certain adults with HR-positive, HER2-negative, locally advanced or metastatic breast cancer. The treatment is intended for patients whose ESR1 mutation is detected during treatment with an aromatase inhibitor and CDK4/6 inhibitor, according to a Sept. 4 FDA news release.
The ESR1 mutation can develop during treatment with an aromatase inhibitor. Fewer than 5% of patients have the mutation at diagnosis of HR-positive metastatic breast cancer, but nearly 40% have it after disease progression on an aromatase inhibitor.
In a clinical trial, estimated median progression-free survival was 16 months for patients receiving Etcamah with a CDK4/6 inhibitor, compared with 9.2 months for those receiving an aromatase inhibitor with a CDK4/6 inhibitor.
The FDA also authorized the Guardant360 CDx assay as a companion diagnostic to identify patients with ESR1 mutations for treatment with camizestrant. The accelerated approval was granted to AstraZeneca, and the FDA is requiring confirmatory studies to verify and describe the treatment’s clinical benefit.
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