publication date: Nov. 13, 2020

Drugs & Targets

FDA approves liquid biopsy NGS companion diagnostic test for multiple cancers and biomarkers

FDA has approved the liquid biopsy next-generation sequencing-based FoundationOne Liquid CDx test Oct. 26 and Nov. 6 as a companion diagnostic device for multiple additional biomarkers detected in cell free-DNA isolated from plasma specimens.

The FoundationOne Liquid CDx test is sponsored by Foundation Medicine Inc.

The companion diagnostic indications in the October 26 approval are:

To identify mutations in BRCA1 and BRCA2 genes in patients with ovarian cancer eligible for treatment with Rubraca (rucaparib, sponsored by  Clovis Oncology Inc.

To identify ALK rearrangements in patients with non-small cell lung cancer eligible for treatment with Alecensa (alectinib, sponsored by Genentech USA Inc.).

To identify mutations in the PIK3CA gene in patients with breast cancer eligible for treatment with Piqray (alpelisib, sponsored by Novartis Pharmaceutical Corp.)

On Nov. 6, FDA approved the FoundationOne Liquid CDx test as a companion diagnostic device to identify mutations in BRCA1, BRCA2 and ATM genes in patients with metastatic castration resistant prostate cancer eligible for treatment with Lynparza (olaparib, sponsored by AstraZeneca Pharmaceuticals LP).

FoundationOne Liquid CDx approval as a companion diagnostic for rucaparib, alpelisib, alectinib, and olaparib was based on the retrospective testing with FoundationOne Liquid CDx of available plasma samples from patients enrolled in four clinical trials that supported the approval of associated therapeutics.

Efficacy for rucaparib, alpelisib, alectinib, and olaparib was shown to be maintained in patients with confirmed BRCA1 and/or BRCA2 gene alterations, PIK3CA mutations, ALK rearrangement, and BRCA1, BRCA2, and/or ATM gene alterations, respectively, by FoundationOne Liquid CDx.

 

FDA issues guidance to enhance diversity in … Continue reading FDA approves liquid biopsy NGS companion diagnostic test for multiple cancers and biomarkers

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