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Newsflash: First Oral SERD Orserdu (elacestrant) FDA-Approved  

January 31, 2023

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What was announced?

The FDA has issued its approval for an important new option for post-menopausal women and men with HR+, HER2- metastatic breast cancer with progression on at least one line of endocrine therapy, and an ESR1 mutation. 

Orserdu (elacestrant) is an oral selective estrogen receptor degrader (SERD) and is the first oral option with FDA approval for patients with estrogen receptor-positive breast cancer. 

The approval is indicated for use in patients with ER-positive, HER2-negative, ESR1-mutated advanced metastatic breast cancer who have had disease progression after at least one line of endocrine therapy. The Emerald Trial that led to this approval found that patients who had been on endocrine therapy plus a CDK 4/6 inhibitor for at least 12 months and had an ERS1 mutation had the most benefit from Orserdu.

The only other SERD that’s currently FDA-approved is an injection called fulvestrant (Faslodex). Many oral SERDs are being studied in clinical trials, but Orserdu is the first to gain regulatory approval.

Who does it impact?

Post-menopausal women and men living with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer who have had disease progression after at least one line of endocrine therapy.

Why should I care about it?

Approximately 2 out of 3 breast cancers are hormone receptor-positive, meaning they are stimulated by hormones such as estrogen and progesterone. Hormone positive tumors are often treated with hormone therapy, which aims to reduce the amount of hormones in the body or block the effects of hormones on the cancer cells. 

In ER-positive, HER2-negative metastatic breast cancer, hormone therapy plus a CDK 4/6 inhibitor is a first-line treatment and is often very effective at slowing progression. Unfortunately, these tumors eventually achieve drug resistance and this resistance may be driven by an ESR1 mutation in the tumor. Oserdu is a potentially effective option for patients who stop responding to first-line treatment.

SERDs like Orserdu work by binding to the estrogen receptor and inducing its degradation, thereby preventing the activation of downstream signaling pathways that drive cancer cell growth and proliferation. This is in contrast to traditional hormone therapy, which works by blocking the binding of estrogen to the receptor or reducing the amount of estrogen available to the cancer cells.

For more information, view the FDA announcement.

Curious about your ESR1 Status? 

If you were diagnosed with ER-positive, HER2-negative metastatic breast cancer and are now wondering if this new therapy is an option for your cancer, you are not alone! Outcomes4Me has a team of oncology nurse practitioners that would be happy to review your medical records and consult with you. If you have specific questions, please submit them through the app using the AskOutcomes4Me button.