New Drug Approved to Treat Metastatic Breast Cancer Patients with ESR1 Mutations

Innovative drug offers a novel option for those living with ER+, HER2- metastatic breast cancer

The U.S. Food and Drug Administration has just approved its first new hormone therapy in more than 20 years: ORSERDU™ (elacestrant), the first and only prescription endocrine therapy specifically indicated for patients with an ERS1 mutation. 

ORSERDU, an oral once-daily medication, is approved for women who have gone through menopause and adult men with ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer, whose disease has progressed after endocrine therapy

With up to 40% of metastatic breast cancer patients developing an ESR1 mutation after progression on initial endocrine therapy, the introduction of ORSERDU addresses what has been a major unmet need. ESR1 mutations are a known driver of resistance to standard endocrine therapy, and prior to now, have been difficult to treat.

The approval of ORSERDU, a selective estrogen receptor degrader (SERD), was supported by results from the Phase III EMERALD study, the largest randomized global Phase III trial to include patients with the ESR1 mutations. In the group of patients whose tumors had ESR1 mutations, elacestrant reduced the risk of progression or death by 45%, with safety data consistent with other endocrine therapies.

“We urgently need new and better treatment options to extend and improve the lives of people with metastatic breast cancer,” said Sonya Negley, Executive Director of Metavivor. “We are thrilled to see the approval of ORSERDU for patients who have tumors that harbor ESR1 mutations, which are present in up to 40% of ER+, HER2- advanced or metastatic breast cancer. We advise patients to get tested for ESR1 mutations at progression in their metastatic treatment, so that their healthcare team can identify the right treatment options for their disease.“

Stemline Therapeutics, a subsidiary of Menarini Group and a new industry member of the MBC Alliance, will soon make ORSERDU available in the United States. Stemline ARC, a patient support program, is available to help guide eligible patients through the steps of getting started on treatment, from education on the drug to understanding insurance coverage and identifying potential financial assistance options. For more information, patients and healthcare professionals can call 1-833-4-STEMLINE (1-833-478-3654).

Read the latest news & full prescribing information for ORSERDU.

Download an FAQ sheet on ORSERDU.