Elacestrant (Orserdu): A Novel Breast Cancer Medicine is Now Approved

On January 27, 2023, the Food and Drug Administration approved Elacestrant (Orserdu) pills as the first treatment for postmenopausal females or adult males with ER+/HER2- and ESR1-mutated advanced or metastatic (cancer that has progressed to other parts of the body) breast cancer who have experienced disease progression following at least a single line of endocrine therapy.

In addition to this approval, the agency has also approved the Guardant360 assay companion diagnostic device to identify patients with breast cancer for treatment with Elacestrant (Orserdu).

The efficacy of this medicine was assessed in a randomized, open-label, active-controlled, multicenter trial (EMERALD) in which a total of 478 postmenopausal females and males with ER+Ve/HER2-Ve advanced or metastatic breast cancer were enrolled. Additionally, 228 candidates in this population had ESR1 mutations. Enrolled patients were randomized (1:1) to take Elacestrant (Orserdu) 345 mg orally once a day or the evaluator`s choice of endocrine therapy.

The significant efficacy result measure was PFS. As per an agency press release, a statistically notable difference in PFS was seen in the whole population and in the subgroup of those with ESR1 mutations. In those with ESR1 mutations, PFS was noted as 3.8 months for those treated with Elacestrant (Orserdu) vs 1.9 in those treated with a sequester endocrine therapy.

The proposed dose is Elacestrant 345 mg taken orally (by mouth) with food once a day until the disease is progressive or any kind of unacceptable toxicity occurs. Before this approval, Elacestrant (Orserdu) was granted priority review and fast-track designation.

About Elacestrant (Orserdu):

Elacestrant (Orserdu) is a new and different treatment option. It is an oral selective estrogen receptor downregulator (SERD) for metastatic, ER+/HER2 negative, and ESR1-mutated breast cancer. The drug is used in postmenopausal women or adult men with breast cancer that has progressed/spread after being treated with endocrine therapy.

Elacestrant (Orserdu) is supplied as 345 mg and 86 mg tablet that is taken once a day with food. Do not use this medicine during pregnancy. Elacestrant (Orserdu) tablets can cause fetal harm if administered to pregnant women.

Reference:

https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-elacestrant-er-positive-her2-negative-esr1-mutated-advanced-or-metastatic-breast-cancer