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FDA Approves Foundation Medicine CDx for Novartis Breast Cancer Drug Piqray

NEW YORK – Foundation Medicine said on Wednesday that the US Food and Drug Administration has approved its FoundationOne CDx test as a companion diagnostic for alpelisib (Novartis' Piqray) in combination with fulvestrant (AstraZeneca's Faslodex) for the treatment of postmenopausal women, as well as men, with hormone receptor-positive, human epidermal growth factor receptor 2-negative, PIK3CA-mutated, advanced or metastatic breast cancer following progression on or after an endocrine-based treatment.

The decision expands the use of FoundationOne CDx, which has already been approved by the FDA as a companion diagnostic for more than a dozen other targeted drugs, most recently olaparib (AstraZeneca's and Merck's Lynparza).

About 40 percent of patients with HR+/HER2- breast cancer have a mutation in PIK3CA, making it the most commonly mutated gene in this type of cancer. Professional guidelines were updated in September to recommend testing for PIK3CA mutations in patients with this breast cancer.

Foundation Medicine, a unit of Roche, said it has an ongoing collaboration with Novartis to support the development of companion diagnostics for the pharma company's cancer drugs.