AIFA approves new targeted therapy for metastatic breast cancer

The Italian Medicines Agency has approved the reimbursement of elacestrant, a targeted hormone therapy targeting a specific mutation in metastatic breast cancer. The novel selective estrogen receptor degrader has been approved for patients with ESR1 mutations who have already received first-line endocrine therapy in combination with CDK4/6 inhibitors. The news was announced by Menarini Stemline Italia, a subsidiary of the Menarini Group.

"Hormone receptor-positive, HER2-negative breast cancer accounts for two-thirds of all cases of this malignancy. Prolonged exposure to the endocrine therapies used to treat it," says Lucia Del Mastro, director of Medical Oncology at the IRCCS San Martino in Genoa, "often leads to the acquisition of mutations in the estrogen receptor ESR1, which develops in approximately 50% of patients."

The new hormone therapy is designed to overcome this resistance mechanism. Elacestrant belongs to the class of drugs called Serd, which selectively destroy the estrogen receptor. A clinical study involving 478 patients found that elacestrant reduced the risk of progression or death by 45%. "The results," explains Giuseppe Curigliano, professor of Medical Oncology at the University of Milan, "demonstrate the added therapeutic value of this drug, which is taken orally and therefore easy to administer."

To identify genomic alterations in the blood that indicate resistance to conventional treatments but also response to innovative drugs, "liquid biopsy, based on a simple blood sample, is increasingly important," explains Adriana Bonifacino, founder of the IncontraDonna Foundation. "Elacestrant," concludes Monica Binaschi, director of the Department of Preclinical and Translational Sciences at Menarini Ricerche, "is an example of our commitment: a targeted therapy that addresses an unmet clinical need for patients with poor prognosis and resistance to previous treatments."