ORSERDU elacestrant

Drug Class

Selective estrogen receptor degrader (SERD)

Mechanism

Binds to estrogen receptor alpha (ER-alpha) to inhibit estradiol-induced cell proliferation and induce receptor degradation, blocking estrogen signaling pathways.

Approved Indication

FDA-approved for postmenopausal women or adult men with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following endocrine therapy.

What This Means For Patients

ORSERDU is an oral endocrine therapy targeting ESR1-mutated advanced or metastatic breast cancer. It is approved by the FDA and EMA and is clinically accessible under Hainan pilot zone rules.

Regulatory Approvals

• FDA — approved (2023) — label
• EMA — approved (2023) — source

Pivotal Clinical Evidence

• EMERALD — Bidard et al., J Clin Oncol 2022 (NCT03778931) — DOI

Sources

• https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217639s000lbl.pdf
• https://www.ema.europa.eu/en/medicines/human/EPAR/orserdu