Skip to main content
Premium Trial:

Request an Annual Quote

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.

The Scan

Positive Framing of Genetic Studies Can Spark Mistrust Among Underrepresented Groups

Researchers in Human Genetics and Genomics Advances report that how researchers describe genomic studies may alienate potential participants.

Small Study of Gene Editing to Treat Sickle Cell Disease

In a Novartis-sponsored study in the New England Journal of Medicine, researchers found that a CRISPR-Cas9-based treatment targeting promoters of genes encoding fetal hemoglobin could reduce disease symptoms.

Gut Microbiome Changes Appear in Infants Before They Develop Eczema, Study Finds

Researchers report in mSystems that infants experienced an enrichment in Clostridium sensu stricto 1 and Finegoldia and a depletion of Bacteroides before developing eczema.

Acute Myeloid Leukemia Treatment Specificity Enhanced With Stem Cell Editing

A study in Nature suggests epitope editing in donor stem cells prior to bone marrow transplants can stave off toxicity when targeting acute myeloid leukemia with immunotherapy.