Elacestrant Earns EU Approval for ESR1+, ER+, HER2– Advanced Breast Cancer

News
Article

The regulatory decision to approve elacestrant in European patients with estrogen receptor–positive, HER2-negative locally advanced or metastatic breast cancer and an activating ESR1 mutation was based on data from the phase 3 EMERALD study.

"Today’s approval gives us the first-ever treatment option that directly acts against the very mutations that make this form of breast cancer more difficult to treat, and provides hope to our patients and their families," according to Giuseppe Curigliano, MD, PhD.

"Today’s approval gives us the first-ever treatment option that directly acts against the very mutations that make this form of breast cancer more difficult to treat, and provides hope to our patients and their families," according to Giuseppe Curigliano, MD, PhD.

The European Commission has granted approval to elacestrant (Orserdu) for those with ESR1-mutant, estrogen receptor (ER)–positive, HER2-negative locally advanced or metastatic breast cancer who progressed after a minimum of 1 line of endocrine therapy including a CDK4/6 inhibitor, according to a press release from the Menarini Group.1

The approval was based on findings from the phase 3 EMERALD study (NCT03778931) in which patients treated with elacestrant experienced a statistically significant progression-free survival benefit over standard of care at a median of 3.8 months and 1.9 months, respectively. This translated to a 45% reduction in risk of progression or death (HR, 0.55; 95% CI, 0.39-0.77).

Frequent adverse effects associated with elacestrant include nausea, triglyceride increase, cholesterol increase, vomiting, fatigue, dyspepsia, diarrhea, calcium decrease, back pain, creatinine increase, arthralgia, sodium decrease, constipation, headache, hot flush, abdominal pain, anemia, potassium decrease, and alanine aminotransferase increase.

“With a significant number of patients [with ER–positive, HER2-negative disease] ultimately developing ESR1 mutations at some point in their metastatic journey, it is important to test for ESR1 each time a patient [with metastatic breast cancer] experiences disease progression, to understand what is fueling their [disease],” Giuseppe Curigliano, MD, PhD, professor of Medical Oncology at the University of Milano and the head of the Division of Early Drug Development at the European Institute of Oncology, IRCCS, Italy, said in the press release. “Today’s approval gives us the first-ever treatment option that directly acts against the very mutations that make this form of breast cancer more difficult to treat, and provides hope to our patients and their families.”

Elacestrant was approved by the FDA in January 2023 for those with ER–positive, HER2-negative, ESR1-mutant advanced or metastatic breast cancer following a minimum of one line of therapy along with the Guardant 360 CDx assay.2 This decision was also based on data from the phase 3 EMERALD study.

References

  1. European Commission approves Menarini Group’s ORSERDU® (Elacestrant) for the treatment of patients with ER+, HER2- locally advanced or metastatic breast cancer with an activating ESR1 mutation. News release. The Menarini Group. September 20, 2023. Accessed September 20, 2023. https://bit.ly/3riFDVz
  2. FDA approves elacestrant for ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer. News release. FDA. January 27, 2023. Accessed September 20, 2023. bit.ly/3kQrxHq
Recent Videos
Heather Zinkin, MD, states that reflexology improved pain from chemotherapy-induced neuropathy in patients undergoing radiotherapy for breast cancer.
Study findings reveal that patients with breast cancer reported overall improvement in their experience when receiving reflexology plus radiotherapy.
Patients undergoing radiotherapy for breast cancer were offered 15-minute nurse-led reflexology sessions to increase energy and reduce stress and pain.
Whole or accelerated partial breast ultra-hypofractionated radiation in older patients with early breast cancer may reduce recurrence with low toxicity.
Ultra-hypofractionated radiation in those 65 years or older with early breast cancer yielded no ipsilateral recurrence after a 10-month follow-up.
The unclear role of hypofractionated radiation in older patients with early breast cancer in prior trials incentivized research for this group.
Patients with HR-positive, HER2-positive breast cancer and high-risk features may derive benefit from ovarian function suppression plus endocrine therapy.
Paolo Tarantino, MD discusses updated breast cancer trial findings presented at ESMO 2024 supporting the use of agents such as T-DXd and ribociclib.
Paolo Tarantino, MD, discusses the potential utility of agents such as datopotamab deruxtecan and enfortumab vedotin in patients with breast cancer.
Paolo Tarantino, MD, highlights strategies related to screening and multidisciplinary collaboration for managing ILD in patients who receive T-DXd.
Related Content