Breast cancer, ok from EU to drug for advanced cases

Alpelisib, the first drug targeted for advanced breast cancer with PIK3CA genetic mutation, responsible for tumor growth and normally associated with poor response to therapy, approved in Europe. This was announced by Novartis, which highlights how the European Commission has approved alpelisib in combination with the fulvestrant molecule for the treatment of postmenopausal women and men with advanced breast cancer, with hormone receptors positive / HER2 negative, with PIK3CA mutations after progression of the disease.

"PIK3CA is the most common mutated gene in breast cancer - notes Pierfranco Conte, director of the Division of Medical Oncology 2, Veneto Oncological Institute of Padua - and this mutation is present in about 40% of patients with HR + / HER2 negative breast cancer, a subtype which represents about 60% of all breast cancers. "
"Alpelisib - adds the expert - represents a new hope for patients with advanced breast cancer with a PIK3CA mutation, also considering that these patients unfortunately have a worse overall prognosis. This mutation, as well as for breast cancer, could are also of great interest in other cancers, such as those in the head, neck and ovary, and studies are underway to verify the efficacy of the drugs directed against this mutation ". Approval is based on the phase III SOLAR-1 study, which demonstrates that the alpelisib plus fulvestrant combination nearly doubled median progression-free survival (11.0 versus 5.7 months) compared to fulvestrant in monotherapy.

"It will be essential - underlines Luigi Boano, General Manager of Novartis Oncology Italy - to collaborate, as we have always done, with the Italian scientific community to make people understand the importance of identifying the mutation with validated tests, which today in Italian clinical practice are not still so widespread. "
Patients with advanced HR + / HER2 breast cancer may be eligible for treatment with alpelisib if the presence of the PIK3CA mutation is found in tumor or plasma samples, through the use of a validated test. If no mutation is detected in a plasma sample, tumor tissue should be tested, if available. In Italy in the last year 53,000 cases of breast cancer have been estimated, of which 30% in an advanced stage, and about 40% of those with HR + / HER2 subtype have a PIK3CA mutation, associated with a worse prognosis.

In collaboration with:
Novartis