EU approves Novartis’s advanced breast cancer drug
EU regulators have approved Novartis’s new Piqray drug to treat advanced breast cancer, the Swiss pharma giant said Wednesday.
The European Commission approved sales of the inhibitor drug — also known as alpelisib — for patients suffering from advanced cancer with a PIK3CA gene mutation for taking along with hormonal drug Fulvestrant.
The move had been expected with the human medicines committee of the European Medicines Agency having already recommended approval of Piqray.
The drug was approved last year in the United States and is also on sale in several other countries including Switzerland, Canada and Australia.
Some 340,000 advanced breast cancer cases are discovered globally each year. The PIK3CA mutation is the most common, occurring in some 40 percent of sufferers of hormone receptor and human epidermal receptor forms of the disease.