EC approves Menarini Group’s Orserdu for breast cancer treatment
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.
Elcin Barker Ergun, CEO of the Menarini Group, commented: “We have long known that patients living with metastatic breast cancer need effective and tolerable options which treat their disease while enabling them to focus on the things that matter to them. We are proud of delivering a new breast cancer treatment that offers efficacy in a once-daily pill and represents the first innovation in endocrine therapy in nearly two decades; we are also incredibly grateful for the support of the oncology researchers and all the patients who participated in the clinical studies that made today’s achievement possible.”
Genentech, a member of the Roche Group, has announced positive results from the phase 3 …
Almirall has announced that the European Commission (EC) has approved Ebglyss (lebrikizumab) for the treatment …