And drugnow also available in Italiawhich decreases the chances of relapse or metastasis in those who have been diagnosed with breast cancer in the initial stages with a “dangerous” type of neoplasm. It’s called abemaciclib and can be used in addition to standard hormonal care after surgery. The data presented in the USA during the oncology congress in Chicago were considered of extreme clinical relevance. Now there is the green light in Italy too, with AIFA which has approved its reimbursement. The monarchE study demonstrated a statistically significant improvement in invasive disease-free survival in patients treated with abemaciclib compared to standard treatment.
FURTHER INFORMATION
Breast cancer treatment reduces the risk of recurrence by 25%: key role of the molecule ribociclib
Breast cancer, the monarchE study
Breast cancer is the most common in Italy (about 55,000 new cases diagnosed each year) and despite progress (87% of patients are alive 5 years after diagnosis) it remains the leading cause of death from cancer among Italians. The trial involved 5,637 subjects with hormone-sensitive, hormone receptor positive (HR+) and human epidermal growth factor receptor negative (HER2-) breast cancer, who were lymph node positive and had a high risk of recurrence. Patients were treated with abemaciclib in combination with hormone therapy for two years. The results indicate that the risk of developing a invasive disease it was reduced by 35%; the four-year invasive disease-free survival rate was 85.5% for patients receiving abemaciclib plus hormone therapy compared with 78.6% for those receiving hormone therapy alone. With the addition abemaciclib in the adjuvant (ie after the operation) it also reduced the risk of developing metastatic disease by 35%.
In Italy, abemaciclib was already approved and reimbursed by Aifa since 2019 for the treatment of women with HR+ and HER2- locally advanced or metastatic breast cancer, in combination with an aromatase inhibitor or fulvestrant, as initial endocrine therapy, or in women who have received previous endocrine therapy.
Metastatic breast cancer, ok from the EMA committee to the new drug
Meanwhile, in recent days the green light has arrived from the Committee for Medicinal Products for Human Use of the European Medicines Agency ad exult, 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 US 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.