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European Commission Approves Novartis' Piqray, Fulvestrant for PIK3CA-Mutated Breast Cancer

NEW YORK – The European Commission has approved alpelisib (Novartis' Piqray) in combination with fulvestrant for the treatment of post-menopausal women, and men, with hormone receptor- and HER2-positive advanced or metastatic breast cancer with PIK3CA mutations. Patients must have progressed on endocrine therapy first.

In May, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended approval for the alpelisib-fulvestrant combination in this indication. CHMP's positive opinion was based on the Phase III SOLAR-1 trial showing that adding alpelisib to fulvestrant nearly doubled median progression-free survival in patients and more than doubled overall response rate, compared to those receiving just fulvestrant.  

Patients eligible to receive alpelisib must have PIK3CA mutations in tumor tissue or plasma samples as detected by a validated test. "Knowledge of PIK3CA status can better equip doctors as they develop a personalized upfront treatment plan for patients," Kees Roks, head of Novartis Oncology in the European region, said in a statement.

Data from SOLAR-1 supported approval of this same indication by the US Food and Drug Administration in March 2019. Simultaneously, the agency also approved Qiagen's Therascreen PIK3CA RGQ PCR Kit as a companion diagnostic for identifying advanced breast cancer patients with PIK3CA mutations who are likely to respond to alpelisib. The test is designed to analyze PIK3CA mutations in tissue and blood samples. Patients who are mutation negative by liquid biopsy analysis should undergo tumor biopsy for tissue analysis.