CHMP recommends Orserdu to treat patients with ER+, HER2- locally advanced or metastatic breast cancer with an activating ESR1 mutation.- Menarini + Stemline Therapeutics.
The Menarini Group and Stemline Therapeutics Inc. a wholly-owned subsidiary of the Menarini Group, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion on the approval of Orserdu (elacestrant) monotherapy, indicated for the treatment of postmenopausal women, and men, with estrogen receptor (ER)?positive, HER2-negative, locally advanced or metastatic breast cancer with an activating ESR1 mutation who have disease progression following at least one line of endocrine therapy including a CDK 4/6 inhibitor.
The CHMP opinion will now be reviewed by the European Commission, which has the authority to grant marketing authorization for human medicines throughout the European Union (EU). If approved, Stemline and its affiliates will commercialize the product within Europe. Orserdu would be 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 as a result of exposure to endocrine therapy, and they are found in up to 40% of patients with ER+, HER2- mBC. ESR1 mutations are a known driver of resistance to standard endocrine therapy, and until now, the tumors that harbor these mutations have been more difficult to treat.
Orserdu, if approved, will also provide a convenient daily oral treatment.
The benefit of Orserdu is an improved progression-free survival (PFS) in patients with ER?positive, HER2?negative advanced breast cancer with an activating ESR1 mutation who had relapsed after at least one prior endocrine therapy in combination with a CDK4/6 inhibitor, when compared to standard of care. The most common side effects are nausea, increased triglyceride and cholesterol levels, vomiting, fatigue, dyspepsia, diarrhoea, decreased calcium, sodium and potassium levels, back pain, increased creatinine levels, arthralgia, constipation, headache, hot flush, abdominal pain, anaemia and increased alanine.
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