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Nov 6, 2026Regulatory decision

FDA approves elacestrant for ER-positive, HER2-negative, ESR1-mutated breast cancer

The agency's approval covers advanced or metastatic breast cancer marked by ER-positive, HER2-negative status and an ESR1 mutation.

The FDA has approved elacestrant for patients with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer, according to the agency's announcement. FDA approves elacestrant for ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer1

The posted record does not include additional details such as trial data, dosing information, or the approval date beyond the title of the notice itself. Readthrough will update this entry if the FDA publishes further specifics on the approval.

Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.