The Lynx Group

FDA Expands FoundationOne Liquid CDx Indications for Several Mutations in Various Cancers

December 2020, Vol 11, No 6

In October and November, the FDA approved FoundationOne Liquid CDx (Foundation Medicine), a next-generation sequencing liquid biopsy test, for the identification of multiple cancers and biomarkers.

On October 26, 2020, the FDA approved this test for the following 3 diagnoses: BRCA1 and BRCA2 mutations in women with ovarian cancer who are eligible for rucaparib (Rubraca); ALK rearrangements in patients with non–small-cell lung cancer who are eligible for treatment with alectinib (Alecensa); and PIK3CA mutations in patients with breast cancer who are eligible for treatment with alpelisib (Piqray).

On November 6, 2020, this test was approved for the detection of BRCA1, BRCA2, and ATM mutations in men with metastatic castration-resistant prostate cancer who are eligible for treatment with olaparib (Lynparza).

The FDA’s approval of FoundationOne Liquid CDx as a companion diagnostic for rucaparib, alectinib, alpelisib, and olaparib was based on the retrospective testing results of plasma samples from patients in 4 clinical trials that each included patients with BRCA1 and/or BRCA2 alterations; PIK3CA mutations; ALK rearrangements; or BRCA1, BRCA2, and/or ATM alterations, as detected by FoundationOne Liquid CDx.

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