FDA Approves AstraZeneca's Oral SERD Etcamah for ESR1-Mutated Breast Cancer

The FDA has granted approval to Etcamah (camizestrant), an oral selective estrogen receptor degrader (SERD) from AstraZeneca, for use in combination with a CDK4/6 inhibitor. This first-line treatment is for locally advanced or metastatic HR-positive, HER2-negative breast cancer with a mutation in the ESR1 gene. This marks the first FDA approval of a cancer therapy guided by the detection of a resistance mutation in circulating tumor DNA (ctDNA) before imaging tests show disease progression.