RELEASE: Stemline Therapeutics Receives US FDA Approval for ORSERDUTM (elacestrant) (2)

(Information sent by the signatory company).

RELEASE: Stemline Therapeutics Receives US FDA Approval for ORSERDUTM (elacestrant) (2)

(Information sent by the signatory company)

- Stemline Therapeutics, a subsidiary of Menarini Group, receives US FDA approval of ORSERDUTM (elacestrant) as the first and only treatment specifically indicated for patients with ESR1 mutations in ER , HER2-advanced or metastatic breast cancer.

FLORENCE, Italy and NEW YORK, Jan. 30, 2023 /PRNewswire/ -- Menarini Group ("Menarini"), a leading Italian pharmaceutical and diagnostics company, today announced that the US Food and Drug Administration ( FDA) has approved ORSERDU for the treatment of postmenopausal women or adult men with advanced or metastatic ER , HER2-, ESR1-mutant breast cancer and disease progression after at least one line of endocrine therapy. Stemline Therapeutics ("Stemline"), a wholly-owned subsidiary of the Menarini Group, based in New York and focused on delivering transformative cancer treatments for cancer patients, will commercialize ORSERDU in the United States.

"The FDA approval of ORSERDU marks the first therapy for patients with ER , HER2-advanced or metastatic breast cancer with ESR1 mutations, and we are very proud to offer a targeted therapy that addresses this enormous unmet need," said Elcin Barker. Ergun, CEO of Menarini Group. "We are very grateful to the patients, researchers, and administrators who participated in the clinical trials that led to this remarkable innovation."

ORSERDU is approved under FDA Priority Review and Fast Track designation based on the results of the phase III EMERALD trial, which demonstrated statistically significant progression-free survival (PFS) with elacestrant versus endocrine monotherapy with SOC (fulvestrant, letrozole, anastrozole, exemestane), meeting both primary endpoints in all patients and in those patients whose tumors harbor ESR1 mutations."

In the group of patients whose tumors had ESR1 mutations, elacestrant reduced the risk of progression or death by 45% (PFS PFS=0.55; 95% CI: 0.39, 0.77) versus SOC. A post-hoc analysis of PFS results based on duration of prior CDK4/6i inhibitor (CDK4/6i) use was presented at the San Antonio Breast Cancer Symposium (SABCS) in December 2022. Median PFS was 8.6 months with elacestrant versus 1.9 months with SOC, in patients whose tumors harbored ESR1 mutations and had been treated with a CDK4/6i for at least 12 months.

The safety data is consistent with that of other endocrine treatments. The majority of adverse events (AEs), including nausea and musculoskeletal pain, were grade 1 and 2. No haematological safety signals were observed and none of the patients in either treatment arm developed sinus bradycardia.

"ER, HER2-pretreated advanced or metastatic breast cancer with endocrine therapy remains an area of ​​unmet medical need. The last approved endocrine therapy was about 20 years ago, and effective endocrine options are needed for this patient population," said Dr. Aditya Bardia, MD, MPH, Director of Breast Cancer Research at the Mass General Cancer Center, Associate Professor in the Department of Medicine, Harvard Medical School, and Principal Investigator of the EMERALD trial. "ESR1 mutations are a known factor of resistance to standard endocrine therapy and, until now, have been difficult to treat. Elacestrant's approval is welcome as it offers a novel option for patients with ER, HER2 metastatic breast cancer -.This therapy targets ESR1 mutations in metastatic breast cancer and provides patients with a convenient once-daily oral dose."

"300,000 Americans are diagnosed with breast cancer each year, and metastatic breast cancer causes the vast majority of breast cancer deaths – more than 43,000 a year. We urgently need new and better treatment options to extend and improve the lives of women." people with metastatic breast cancer," said Sonya Negley, CEO of Metavivor. "We are delighted with the approval of ORSERDU, a new oral endocrine treatment, for patients with tumors harboring ESR1 mutations, present in up to 40% of ER , HER2-advanced or metastatic breast cancer cases. We advise patients to are tested for ESR1 mutations in the progression of their metastatic treatment, so that their healthcare team can identify the appropriate treatment options for their disease."

ORSERDU will soon be available in the United States. Stemline is committed to helping patients access ORSERDU and will offer services to overcome barriers to access. Stemline ARC, a patient support program, is available to help guide eligible patients through the various aspects of starting treatment, from providing educational information to helping them understand their insurance coverage and identifying possible assistance options. financial. For more information, patients and healthcare professionals can call 1-833-4-STEMLINE (1-833-478-3654)

Menarini Group obtained the worldwide license rights to elacestrant in July 2020 from Radius Health, Inc. which conducted the EMERALD study. With this approval, Radius will receive milestone payments and royalties from business sales. The Menarini Group is now fully responsible for the global registration, commercialization and further development activities of elacestrant.

About the Phase 3 EMERALD Study (NCT03778931) The Phase 3 EMERALD trial is a randomized, open-label, actively controlled study evaluating elacestrant as second- or third-line monotherapy in patients with ER , HER2- advanced/metastatic breast cancer. The study included 478 patients who had received prior treatment with one or two lines of endocrine therapy, including a CDK4/6 inhibitor. Patients in the study were randomized to receive either elacestrant or the approved hormonal agent chosen by the investigator. The primary endpoints of the study were progression-free survival (PFS) in the total patient population and in patients with mutations in the estrogen receptor 1 (ESR1) gene.

About ORSERDU (elacestrant) The US Food and Drug Administration (FDA) has approved ORSERDU for the treatment of postmenopausal women or adult men, with advanced or metastatic ER , HER2-, ESR1-mutated breast cancer, with disease progression after at least one line of endocrine therapy. The Marketing Authorization Application (MAA) is under review by the European Medicines Agency (EMA).

Elacestrant is also being investigated in several clinical trials in metastatic breast cancer, alone or in combination with other therapies: ELEVATE (NCT05563220); ELECTRA ( NCT05386108); ELONA (NCT05618613); ELCIN (NCT05596409). Elacestrant is also planned to be tested in early breast cancer disease.

Full prescribing information can be found at

Important Safety Information

Warnings and Cautions

Dyslipidemia: Hypercholesterolemia and hypertriglyceridemia occurred in patients taking ORSERDU at an incidence of 30% and 27%, respectively. The incidence of grade 3 and 4 hypercholesterolemia and hypertriglyceridemia was 0.9% and 2.2%, respectively. Check the lipid profile before starting to take ORSERDU and periodically while taking it.

Embryo-Fetal Toxicity: Based on animal findings and its mechanism of action, ORSERDU may cause fetal harm when administered to a pregnant woman. Advise pregnant women and women of childbearing potential about the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment with ORSERDU and for 1 week after the last dose. Advise male patients with female partners of reproductive age to use effective contraception during ORSERDU treatment and for 1 week after the last dose.

Adverse reactions

Serious adverse reactions occurred in 12% of patients receiving ORSERDU. Serious adverse reactions in >1% of patients receiving ORSERDU were musculoskeletal pain (1.7%) and nausea (1.3%). Fatal adverse reactions occurred in 1.7% of patients receiving ORSERDU, including cardiac arrest, septic shock, diverticulitis, and unknown cause (one patient each).

The most common adverse reactions (>10%), including laboratory abnormalities, for ORSERDU were musculoskeletal pain (41%), nausea (35%), cholesterol increased (30%), AST increased (29%), triglycerides (27%), fatigue (26%), hemoglobin decreased (26%), vomiting (19%), ALT increased (17%), sodium decreased (16%), creatinine increased (16%) ), decreased appetite (15%), diarrhea (13%), headache (12%), constipation (12%), abdominal pain (11%), hot flashes (11%), and dyspepsia (10%).

Drug Interactions

Concomitant use with CYP3A4 inducers and/or inhibitors: Avoid concomitant use of strong or moderate CYP3A4 inhibitors with ORSERDU. Avoid concomitant use of strong or moderate inducers of CYP3A4 with ORSERDU.

Use in specific populations

Lactation: Advise lactating women not to breast-feed during treatment with ORSERDU and for 1 week after the last dose.

Hepatic Impairment: Avoid the use of ORSERDU in patients with severe hepatic impairment (Child-Pugh C). Reduce ORSERDU dose in patients with moderate hepatic impairment (Child-Pugh B).

The safety and efficacy of ORSERDU in pediatric patients have not been established.

To report SUSPECTED ADVERSE REACTIONS, contact Stemline Therapeutics, Inc. at 1-877-332-7961 or FDA at 1-800-FDA-1088 or

Indication ORSERDU (elacestrant) 345 mg Tablets is indicated for the treatment of postmenopausal women or adult men with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-mutation-negative advanced or metastatic breast cancer. ESR1, with disease progression after at least one line of endocrine treatment.

For more information, see the full ORSERDU prospectus here

About Menarini Group Menarini Group is a leading international pharmaceutical and diagnostics company with revenues of more than $4 billion and more than 17,000 employees. Menarini focuses on therapeutic areas with high unmet needs with products for cardiology, oncology, pulmonology, gastroenterology, infectious diseases, diabetology, inflammation and analgesia. With 18 production plants and 9 research and development centers, Menarini products are available in 140 countries around the world. For more information, visit

About StemlineStemline Therapeutics, a subsidiary of the Menarini Group, is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel cancer therapies. Stemline markets Elzonris®, a novel CD123-targeted therapy for patients with plasmacytoid dendritic cell neoplasia (BPDCN), a rare hematologic cancer, in the US and Europe, the only approved treatment for BPDCN in the US and EU until the date. Stemline also markets Nexpovio®, an XPO1 inhibitor for multiple myeloma in Europe from a licensing agreement with Karyopharm. Stemline has a broad portfolio of small molecules and biologics in various stages of development for a range of solid and hematologic cancers.

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