The European Commission approves ORSERDU® (elacestrant) from the Menarini group for the treatment of patients
Monday, September 25, 2023
The Menarini Group ("Menarini"), a leading international pharmaceutical and diagnostics company, and Stemline Therapeutics Inc. ("Stemline"), a wholly owned subsidiary % by the Menarini Group, today announced the approval by the European Commission of ORSERDU® (elacestrant) as monotherapy for the treatment of postmenopausal women and men with locally advanced or metastatic breast cancer ( mBC) estrogen receptor (ER) positive, HER2 negative and with an activating ESR1 mutation, whose disease has progressed after at least one line of endocrine therapy including a CDK 4/6 inhibitor.
The European Commission's approval follows the positive opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), issued in July 2023 . With this approval, ORSERDU becomes the first and only therapy specifically indicated for the treatment of ER+, HER2- tumors that harbor ESR1 mutations . ESR1 mutations are acquired mutations that develop following exposure to endocrine therapy. They are present in nearly 40% of patients with metastatic breast cancer with ER+ and HER2-. ESR1 mutationsare a known factor in resistance to standard endocrine therapy and, until now, tumors carrying these mutations have been more difficult to treat.
“We have long known that patients with metastatic breast cancer need effective and tolerable options to treat their disease and be able to focus on the things that matter to them,” said Elcin Barker Ergun, CEO of the group. Menarini. “We are proud to offer a new treatment for breast cancer that is effective in just one daily tablet, and which represents the first innovation in endocrine therapy in almost twenty years. We are also incredibly grateful for the support of oncology researchers and all the patients who participated in the clinical studies that made this accomplishment possible today. »
“Since a significant number of ER+ HER2- patients eventually develop ESR1 mutations at some point during their metastatic journey, it is important to test for ESR1 whenever a patient with metastatic breast cancer evolves, in order to understand what fuels its breast cancer. With today's approval, we have the first treatment option that directly addresses the mutations that make this form of breast cancer more difficult to treat, and gives hope to our patients and their families. families,” said Giuseppe Curigliano , MD, PhD, professor of medical oncology at the University of Milan .and Head of the Early Drug Development Division at the European Institute of Oncology, IRCCS, Italy.
The approval of ORSERDU is based on data from the phase 3 EMERALD study, which demonstrated statistically significant progression-free survival (PFS) with elacestrant compared to standard of care (SOC), defined as choice of the investigator of an approved endocrine monotherapy. The primary endpoints of the study were PFS in the overall patient population and in patients with ESR1 mutations . In the group of patients whose tumors had ESR1 mutations , elacestrant achieved a median PFS of 3.8 months compared to 1.9 months with standard treatment, and reduced the risk of progression or death rate of 45% (PFS HR = 0.55, 95% CI: 0.39, 0,
A post-hoc subgroup analysis of EMERALD PFS results, presented at the San Antonio Breast Cancer Symposium (SABCS) 2022, showed that duration of prior CDK4/6i treatment was positively associated with longer PFS under elacestrant, but not under standard treatment. For patients with ESR1 mutations treated with CDK4/6i for ≥12 months before randomization in EMERALD, elacestrant achieved a median PFS of 8.6 months compared to 1.9 months on standard therapy , with a 59% reduction in the risk of progression or death (HR = 0.41 95% CI: 0.26 - 0.63).³
The safety data were consistent with previously reported results. The most common adverse reactions (≥10%) with ORSERDU were: nausea, increased triglycerides, increased cholesterol, vomiting, fatigue, dyspepsia, diarrhea, decreased calcium, back pain, increased creatinine, arthralgia, decreased sodium, constipation, headache, flushing, abdominal pain, anemia, decreased potassium, and increased alanine aminotransferase. Important safety information regarding ORSERDU is provided below.
About the Menarini Group
The Menarini Group is a leading international pharmaceutical and diagnostics company, with revenues of more than $4.4 billion and more than 17,000 employees. Menarini focuses on therapeutic areas of unmet need, with products for cardiology, oncology, pulmonology, gastroenterology, infectious diseases, diabetology, inflammation and analgesia. With 18 production sites and 9 research and development centers, Menarini products are available in 140 countries around the world. For more information
