FDA grants priority review to elacestrant for metastatic breast cancer
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The FDA granted priority review to elacestrant for ER-positive, HER2-negative advanced or metastatic breast cancer.
Elacestrant (Menarini Group/Stemline Therapeutics) is a selective estrogen receptor degrader (SERD).
Approximately 70% of metastatic breast cancer cases are ER-positive/HER2-negative.
Standard treatment for ER-positive, HER2-negative metastatic breast cancer consists of endocrine therapy plus a cyclin-dependent kinase (CDK) 4/6 inhibitor. However, the majority of patients with ER-positive metastatic disease develop resistance to treatment, sometimes due to development of ESR1 mutations.
The randomized phase 3 EMERALD trial included 477 postmenopausal patients with ER-positive, HER2-negative metastatic breast cancer who received one or two prior lines of endocrine therapy without chemotherapy in the metastatic setting. All patients had progressed on prior CDK 4/6 inhibitor treatment.
Researchers randomly assigned 239 patients to 400 mg elacestrant daily. The other 238 received standard of care, which consisted of investigator’s choice of fulvestrant or an aromatase inhibitor.
Investigators stratified by ESR1 mutation status (confirmed, n = 228; none detected, n = 249), prior fulvestrant treatment and presence of visceral disease.
PFS by blinded independent review committee assessment among patients with ESR1 mutations, as well as PFS among all patients regardless of ESR1 mutation status, served as primary endpoints. OS, safety, tolerability and quality of life served as secondary endpoints.
As Healio previously reported, the study met both primary endpoints.
Results showed elacestrant reduced risk for disease progression or death by about 30% among all patients and by approximately 45% among those with ESR1 mutation.
Elacestrant exhibited a manageable safety profile, according to researchers.
“The FDA’s acceptance of our [new drug application] with priority review marks an important regulatory milestone for our company,” Elcin Barker Ergun, CEO of Menarini Group, said in a press release. “We look forward to working with the FDA during its review of this submission, which addresses a new potential therapeutic option for a major unmet need in the management of patients with advanced or metastatic breast cancer after resistance builds in the earlier lines of the treatment.”
The FDA is expected to make a decision on approval of elacestrant for this indication by Feb. 17, 2023.
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