Elacestrant: First Approval

Area of Science:

• Endocrinology
• Oncology
• Pharmacology

Background:

• Elacestrant (ORSERDU™) is an oral selective estrogen receptor degrader (SERD).
• It is developed for estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer.
• Elacestrant targets ER-positive, HER2-negative advanced or metastatic breast cancer with ESR1 mutations.

Purpose of the Study:

• To summarize the development milestones of elacestrant.
• To highlight the first approval of elacestrant for a specific breast cancer indication.
• To provide an overview of elacestrant's journey to market.

Main Methods:

• Review of elacestrant's development history.
• Analysis of regulatory submissions and approvals.
• Summary of clinical trial outcomes leading to approval.

Main Results:

• Elacestrant received its first US FDA approval in January 2023.
• Approval is for postmenopausal women or adult men with specific breast cancer characteristics.
• Regulatory assessment is ongoing in the EU.

Conclusions:

• Elacestrant represents a novel oral SERD for ER-positive, HER2-negative, ESR1-mutated breast cancer.
• The drug offers a new therapeutic option for patients with advanced or metastatic disease.
• This approval signifies progress in personalized endocrine therapy for breast cancer.