Each year, around 350 people in Slovenia and 334,000 people worldwide are diagnosed with advanced breast cancer. About 40% of those with HR+/HER2- subtype have a PIK3CA mutation, which is associated with a poor prognosis.
STA, 8 June 2021 - Alpelisib, the first and only targeted therapy for a specific type of advanced breast cancer is now accessible to patients in Slovenia, making it one of the few countries where this drug is available. The Institute of Oncology already started treating patients in the compassionate use programme before the drug was registered.
The European Commission approved the drug called Alpelisib in July 2020, following a positive opinion given by the European Medicines Agency in May 2020. The active ingredient for this medicine is manufactured at Novartis Technical Operations in Mengeš, Slovenia.
According to Novartis, Alpelisib is the first and only drug specifically approved for people with advanced breast cancer whose tumours contain the PIK3CA mutation, which promotes tumour growth and is associated with poor response to treatment.
At the Institute of Oncology in Ljubljana, 25 patients are being treated within the compassionate use programme, where the manufacturer makes medicines available free of charge, Radio Slovenia reported.
Alpelisib is an expensive drug, as monthly treatments cost between EUR 3,000 and EUR 4,000, with an average treatment time of one year.
According to Novartis, knowing the PIK3CA mutation status allows doctors to tailor a personalised treatment plan for patients. Those with advanced breast cancer may be selected for treatment with Alpelisib based on the presence of a PIK3CA mutation in tumour samples.