Elacestrant (Orserdu) is a novel endocrine therapy agent that demonstrates significant value in the treatment of advanced breast cancer with specific gene mutations. As an estrogen receptor antagonist, this drug exerts precise effects on estrogen receptors, providing a new treatment option for patients who have previously received endocrine therapy.

What Are the Indications for Elacestrant (Orserdu)?

Treatment of ER-positive, HER2-negative Advanced Breast Cancer

Elacestrant is indicated for the treatment of postmenopausal women and adult men with ER-positive, HER2-negative, ESR1-mutant advanced or metastatic breast cancer.

These patients must have experienced disease progression following at least one line of endocrine therapy.

Eligible Patient Population

Patients with ER-positive, HER2-negative breast cancer.

Patients harboring ESR1 gene mutations.

Patients who have previously received at least one line of endocrine therapy.

Patients with advanced or metastatic breast cancer that has progressed.

Genetic Testing Requirements

Patients selected for elacestrant therapy must be identified based on the presence of ESR1 mutations.

ESR1 mutation status must be confirmed using an FDA-approved testing method.

Dosage Form and Appearance of Elacestrant (Orserdu)

345 mg Tablet Description

Color: Light blue.

Shape: Oval, biconvex film-coated tablet.

Marking Feature: Imprinted with "MH" on one side.

86 mg Tablet Description

Color: Light blue.

Shape: Round, biconvex film-coated tablet.

Marking Feature: Imprinted with "ME" on one side.

Storage Conditions for Elacestrant (Orserdu)

Standard Storage Conditions

Storage Temperature: 20°C to 25°C (68°F to 77°F).

Permissible Temperature Fluctuation Range: 15°C to 30°C (59°F to 86°F).

Shelf-Life Requirements After First Opening

Use within 6 weeks after the bottle is first opened.

Discard any unused elacestrant after 6 weeks.

Mandatory Storage Regulations

Dispense and store the drug in its original packaging.

Protect the drug from moisture.