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The FDA approved vepdegestrant on 1 May for adults with estrogen receptor-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer.
The indication applies after disease progression following at least one line of endocrine therapy and requires detection of the ESR1 mutation by an FDA-authorized test.
Vepdegestrant is described by FDA as a heterobifunctional protein degrader, placing the approval within a broader shift toward molecularly defined cancer treatment.
Sourcing note: Indication language, biomarker requirement and drug class are from FDA. This article does not provide treatment advice.
Why It Matters
Breast-cancer treatment is becoming more conditional on molecular signals. The ESR1 requirement shows how approvals increasingly pair a drug with a defined diagnostic pathway.
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