The Food and Drug Administration has approved a breast cancer treatment that patients begin when a blood test detects resistance, before any scan shows the cancer growing. The agency says it is the first time it has cleared a cancer therapy on that basis, and it changes when a treatment decision gets made rather than only what the treatment is.
The drug is camizestrant, sold as Etcamah, approved under accelerated approval in combination with a CDK4/6 inhibitor for adults with hormone receptor positive, HER2 negative locally advanced or metastatic breast cancer. The trigger is detection of an ESR1 mutation during aromatase inhibitor and CDK4/6 inhibitor therapy, identified by an FDA-authorized test.