The FDA has granted accelerated approval to Etcamah (camizestrant), from AstraZeneca, for a common form of advanced breast cancer — with a notable first built into the label: it’s guided by a blood test.
Etcamah is approved with a CDK4/6 inhibitor for adults with HR-positive, HER2-negative locally advanced or metastatic breast cancer, once an ESR1 mutation is detected during aromatase-inhibitor plus CDK4/6 therapy. ESR1 mutations are a common way these tumors become resistant to standard hormone therapy.
The first of its kind
What makes this historic: camizestrant is the first cancer therapy the FDA has approved based on detecting a resistance mutation in circulating tumor DNA (ctDNA) — a “liquid biopsy” — before the cancer visibly progresses on scans. In practice, a routine blood test can flag the emerging ESR1 mutation, prompting a switch to Etcamah before the tumor starts growing again.
Why it matters
It’s a step toward pre-emptive, blood-guided cancer care: acting on a molecular warning sign rather than waiting for imaging to confirm the disease is worsening. As an accelerated approval, continued approval may hinge on confirmatory data, but the ctDNA-triggered approach could become a template for treating resistance across other cancers.