ORSERDU^™

FOR IMMEDIATE RELEASE: 

ORSERDU™ Now Available from Onco360 for the Treatment of Postmenopausal Women or Adult Men, with ER-positive, HER2-negative, ESR1-mutated Advanced or Metastatic Breast Cancer with Disease Progression Following at least One Line of Endocrine Therapy

Louisville, KY —  Onco360^®, the nation’s leading independent Specialty Pharmacy, has been selected by Stemline Therapeutics to be a specialty pharmacy partner for ORSERDU™  (elacestrant), which is an estrogen receptor antagonist indicated for the treatment of postmenopausal women or adult men, with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy.

“Onco360 is honored to partner with Stemline Therapeutics and become a specialty pharmacy provider for ORSERDU patients,” said Benito Fernandez, Chief Commercial Officer, Onco360. “Breast cancer impacts many families, including my own, continued advancement in the treatment options for patients – as offered by ORSERDU – provide us hope on improved outcomes for patients suffering from this devastating disease. We remain dedicated to supporting the highly specialized needs of patients battling previously treated, advanced ESR1-mutant, estrogen receptor-positive, HER2-negative breast cancer patients across the United States.”

According to the National Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER) program, it is estimated that 287,850 new cases of breast cancer will be diagnosed in 2022 in the United States with a corresponding 43,250 deaths in 2022. 68% of newly diagnosed breast cancer patients will have the hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative subtype. 6% of newly diagnosed breast cancer patients will present with metastatic disease, Additionally, dependent on tumor size and extent of lymph node involvement, 13-41% of early-stage breast will recur with distant metastatic disease. ESR1 mutations are believed to occur in up to 40% of ER-positive, HER2-negative metastatic breast cancer patients and arise due to previous exposure to standard endocrine therapies used in earlier lines of treatment. Unfortunately, the five-year overall survival (OS) for metastatic breast cancer patients is only 30%.^1,2,3

ORSERDU is commercialized by Stemline Therapeutics, Inc., a Menarini Group Company. The FDA approval of ORSERDU is based on the results of the Phase III EMERALD Trial (NCT03778931) which evaluated the use of ORSERDU compared to investigator’s choice of fulvestrant or an aromatase inhibitor in postmenopausal women and men with ER-positive, HER2-negative advanced or metastatic breast cancer who had disease progression on one or two prior lines of endocrine therapy, including one line containing a CDK4/6 inhibitor. ORSERDU significantly improved progression-free survival (PFS) by 45% in the above patient population compared to investigator’s choice of fulvestrant or an aromatase inhibitor.⁴  

References:

• Female Breast Cancer — Cancer Stat Facts accessed on 1/30/23
• 20-Year Risks of Breast-Cancer Recurrence after Stopping Endocrine Therapy at 5 Years | NEJM accessed on 1/30/23
• Stemline Therapeutics, a subsidiary of Menarini Group, Receives U.S. FDA Approval for ORSERDU™ (elacestrant) as the First and Only Treatment Specifically Indicated for Patients with ESR1 Mutations accessed on 1/30/23
• United States Prescribing Information.pdf – Google Drive accessed on 1/30/23

Media Contact:

Benito Fernandez, Chief Commercial Officer
[email protected]
516-640-1332