Menarini Group’s Orserdu approved by European Commission for breast cancer

The Menarini Group and its subsidiary Stemline Therapeutics have announced that the European Commission (EC) has approved Orserdu (elacestrant) as a monotherapy for the treatment of post-menopausal women and men with oestrogen receptor (ER)-positive, HER2-negative, locally advanced or metastatic breast cancer (mBC) with an activating ESR1 mutation who have experienced disease progression following at least one prior endocrine therapy.
This approval follows a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP), issued in July 2023. This approval means Orserdu becomes the first and only therapy specifically for this indication.
Data from the phase 3 EMERALD trial supports this approval, demonstrating statistically significant progression-free survival (PFS) with elacestrant compared to standard of care (SOC). Safety data remained consistent with previously reported information; the most common adverse events were nausea, an increase in triglycerides, increased cholesterol, vomiting, fatigue, dyspepsia, diarrhoea, decreased calcium, back pain, increased creatinine, arthralgia, decreased sodium, constipation, headaches, hot flushes, abdominal pain, anaemia, decreased potassium and increased alanine aminotransferase.
Giuseppe Curigliano MD PhD, professor of Medical Oncology at the University of Milano and head of the division of Early Drug Development at the Institute of Oncology, both Italy, added: “With a significant number of ER+ HER2- patients ultimately developing ESR1 mutations at some point in their metastatic journey, it is important to test for ESR1 each time an mBC patient experiences disease progression, to understand what is fuelling their breast cancer. Today’s approval gives us the first-ever treatment option that directly acts against the very mutations that make this form of breast cancer more difficult to treat, and provides hope to our patients and their families.”