FDA Approves Orserdu for Some Patients with Metastatic Breast Cancer

The Food and Drug Administration (FDA) has approved Orserdu (elacestrant) for patients with ER-positive, HER2-negative, ESR1-mutated advanced metastatic breast cancer who have had disease progression after at least one line of endocrine therapy. The approval is indicated for both postmenopausal women and adult men.

Additionally, the Guardant360 CDX assay was approved as a dialogistic device to best identify which patients would be fit for the treatment.

The approval comes based off results from the EMERALD trial, which demonstrated a median progression-free survival (time during and after treatment when the patient lives without disease progression) of 3.8 months with Orserdu versus 1.9 months with fulvestrant or aromatase inhibitor in patients with ESR1 mutations (228 patients).

Patients included in the trial received either Orserdu or investigators choice of endocrine therapy (239 patients), which included fulvestrant (166 patients) or an aromatase inhibitor (73 patients).

The most common side effects, occurring in at least 10% of patients, included musculoskeletal pain, nausea, increased cholesterol, increased AST, increased triglycerides (fat lipid in blood), fatigue, decreased hemoglobin, vomiting, increased ALT, decreased sodium, increased creatinine, decreased appetite, diarrhea, headache, constipation, abdominal pain, hot flush and dyspepsia.

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