The European regulatory approval was based on Phase 3 SOLAR-1 trial, which showed that Piqray plus fulvestrant almost doubled median PFS than fulvestrant alone
Novartis has received the European Commission (EC) approval for its kinase inhibitor Piqray (alpelisib) in combination with fulvestrant to treat a type of breast cancer in postmenopausal women and men.
EC indicated Piqray plus fulvestrant for postmenopausal women, and men, with hormone receptor-positive, human epidermal growth factor receptor-2 negative (HR+/HER2-), metastatic breast cancer with PIK3CA-mutation after using endocrine-based regimen as monotherapy.
The EC approval makes Piqray the first and only treatment available for people with advanced breast cancer, with a PIK3CA mutation that stimulates tumour growth and is related to reduced therapy response, said the company.
Novartis Oncology Europe region head Kees Roks said: “Piqray is an important new therapy for HR+/HER2- advanced breast cancer patients whose tumours have a PIK3CA mutation, and we look forward to making it available in countries across Europe.
“Knowledge of PIK3CA status can better equip doctors as they develop a personalised upfront treatment plan for patients. Piqray offers new hope for advanced breast cancer patients with a PIK3CA mutation, who typically face a worse overall prognosis.”
CHMP granted positive opinion on Piqray based on Phase 3 SOLAR-1 trial
The European regulatory approval follows the European Medicines Agency (EMA)’s committee for medicinal products for human use (CHMP) positive opinion, granted in May 2020.
The CHMP positive opinion was based on Phase 3 SOLAR-1 trial, which showed that Piqray improved the median progression-free survival (PFS) by approximately two-fold than fulvestrant alone.
Also, Piqray plus fulvestrant combination has increased the overall response rate, which reflects the number of patients experiencing a minimum of 30% reduction in overall tumour size, by more than two-folds compared to fulvestrant alone.
The Swiss pharmaceutical firm said that patients for Piqray treatment should be selected based on the presence of a PIK3CA mutation in tumour or plasma specimens, using a validated test. If the mutation is not detected in plasma, tumour tissue should be tested to check the mutation
Piqray has been approved in 48 countries, including the US and European member countries.
In the clinical trial, the most common adverse drug reactions (ADRs) including increased plasma glucose, creatinine, gamma-glutamyltransferase, alanine aminotransferase, lipase, decreased appetite, weight, lymphocyte count, plasma glucose.
Also, the drug-induced rashes, nausea, anaemia, fatigue, stomatitis, vomiting, decreased, hypocalcaemia, alopecia, diarrhoea, hypokalaemia, hypertension, and mucosal inflammation.