Home » Metastatic breast cancer, ok from the EMA committee for a new drug – Medicine

Metastatic breast cancer, ok from the EMA committee for a new drug – Medicine

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Metastatic breast cancer, ok from the EMA committee for a new drug – Medicine

Green light from the Committee for Medicinal Products for Human Use of the European Medicines Agency for elacestrant, a drug indicated for the treatment of a type of advanced or metastatic breast cancer. Already approved by the US Food and Drug Administration based on the results of the Emerald pivotal study, the drug is now available in the United States through Menarini Stemline, a biopharmaceutical company acquired by the Menarini Group in 2020.


More than 550,000 patients are diagnosed with breast cancer every year in Europe. Elacestrant is a selective estrogen receptor degrader (SERD) indicated for the treatment of estrogen receptor positive (ER+) and HER2- receptor negative advanced or metastatic breast cancer in persons who have developed ESR1 mutations after at least one line of treatment.


ESR1 mutations are present in up to 40% of ER+, HER2- advanced or metastatic breast cancers and are a known factor in resistance to standard endocrine therapy, making these cancers more difficult to treat.


Elacestrant is the first and only oral Serd to have successfully completed the last step of clinical development (Phase III) to receive a positive opinion from the CHMP. The opinion will now be reviewed by the European Commission, which has the authority to grant marketing authorization throughout the European Union. If also approved here, it would be the first specific treatment in Europe for patients with ER+, HER2-advanced or metastatic breast cancers with ESR1 mutations.


“Elacestrant has demonstrated efficacy and a manageable safety profile, underlining the potential benefit this therapy could soon bring to the patients we care for and the wider oncology community,” explains Giuseppe Curigliano, professor of medical oncology at the University of Milan and head of early drug development at the European Institute of Oncology.

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