FDA approves breast cancer drug tied to ESR1 mutation test
The FDA has approved a breast cancer drug paired with a test that detects ESR1 mutations in circulating tumor DNA. The drug is one of a wave of new therapies aimed at overcoming resistance to estrogen-receptor-targeted treatments, according to a report by Harrison published in Nature Biotechnology in 2026. The paper describes the approval as part of a broader effort to address that resistance in breast cancer.
Patients with breast cancer whose tumors become resistant to estrogen-receptor therapies now have a treatment option guided by a circulating tumor DNA test for ESR1 mutations.
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