Elacestrant (Orserdu) is a novel estrogen receptor antagonist. It was approved for marketing by the U.S. FDA in 2023, providing a precise treatment option for patients with advanced breast cancer harboring specific gene mutations. Through a unique molecular mechanism acting on the estrogen signaling pathway, this medication demonstrates significant clinical advantages in overcoming endocrine therapy resistance.

What Are the Indications of Elacestrant (Orserdu)?

Main Indication Scope

Elacestrant is indicated for the treatment of postmenopausal women or adult men with estrogen receptor-positive, HER2-negative advanced or metastatic breast cancer, where the presence of ESR1 mutation has been confirmed by an FDA-approved detection method.

The eligible population must have experienced disease progression after receiving at least one line of endocrine therapy.

Patient Selection Criteria

Patients selected to receive elacestrant treatment must undergo strict screening based on ESR1 mutation status.

Mutation testing should be performed using an FDA-approved detection method, with analysis conducted on plasma samples to confirm the mutation.

Pharmaceutical Specifications and Characteristics of Elacestrant (Orserdu)

345 mg Tablets

Appearance: Light blue, oval-shaped, biconvex. One side is engraved with "MH", and the other side is blank.

Each tablet is equivalent to 400 mg of elacestrant hydrochloride (i.e., containing approximately 345 mg of elacestrant free base).

86 mg Tablets

Appearance: Light blue, round-shaped, biconvex. One side is engraved with "ME", and the other side is blank.

Each tablet is equivalent to 100 mg of elacestrant hydrochloride (i.e., containing approximately 86 mg of elacestrant free base).

Ingredients

Tablets of both specifications contain the following inactive ingredients: colloidal silicon dioxide, crospovidone, magnesium stearate (non-animal source), microcrystalline cellulose, silicified microcrystalline cellulose, etc.

Coating ingredients include polyvinyl alcohol, titanium dioxide, polyethylene glycol, FD&C Blue No. 1, and talc.

Storage Conditions for Elacestrant (Orserdu)

Ambient Temperature Control

Elacestrant should be stored at standard room temperature between 20°C and 25°C (68°F and 77°F).

Short-term storage within the range of 15°C to 30°C (59°F to 86°F) is permitted.

Packaging Specification Description

The medication is supplied in bottles containing 30 tablets each, sealed with child-resistant caps.

The National Drug Code (NDC) for the 345 mg tablets is NDC 72187-0102-3.

The National Drug Code (NDC) for the 86 mg tablets is NDC 72187-0101-3.