publication date: Jul. 12, 2019

Drugs & Targets

FDA approves expanded indication for FoundationOneCDx as a companion diagnostic for Lynparza

FDA approved FoundationOneCDx to be used as a companion diagnostic for Lynparza (Olaparib) for first line maintenance therapy in BRCA-mutated advanced ovarian cancer.

The diagnostic is sponsored by Foundation Medicine Inc.

FoundationOne CDx is an FDA-approved comprehensive genomic profiling test for all solid tumors that incorporates multiple companion diagnostics.  FoundationOne CDx detects tumor BRCA1 and BRCA2 mutations including both germline and somatic mutations.

FoundationOne CDx may help identify more women who could benefit from Lynparza as compared to conventional testing methods that only identify germline BRCA mutations. Germline-only BRCA1/2 testing identifies approximately half of all BRCA1/2 mutations.

In December 2018, AstraZeneca and Merck & Co. announced FDA approved Lynparza for use as maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated) advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to 1st-line platinum-based chemotherapy.

Foundation Medicine, AstraZeneca and Merck have an ongoing collaboration to support the development of companion diagnostics for Lynparza in prostate cancer.

FoundationOne CDx is a next-generation sequencing based in vitro diagnostic device for detection of substitutions, insertion and deletion alterations, and copy number alterations in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability and tumor mutational burden using DNA isolated from formalin-fixed paraffin embedded tumor tissue specimens.

FoundationOne CDx is intended as a companion diagnostic to identify patients who may benefit from treatment with certain targeted therapies in accordance with their approved therapeutic product labeling. Additionally, FoundationOne CDx is intended to provide tumor mutation profiling … Continue reading FDA approves expanded indication for FoundationOneCDx as a companion diagnostic for Lynparza

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