FoundationOne®CDx Receives FDA Approval For PARP Inhibitor Lynparza In BRCAm Ovarian Cancer

Pixabay License | Source:  Mohamed Hassan , no changes made.
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Foundation Medicine, Inc. has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOne®CDx to be used as a companion diagnostic for LYNPARZA® (Olaparib) for first line maintenance therapy in BRCA-mutated advanced ovarian cancer. FoundationOne CDx is an FDA-approved comprehensive genomic profiling (CGP) test for all solid tumors that incorporates multiple companion diagnostics.

Founded in 2010, based in the Greater Boston Area, USA, Foundation Medicine is a molecular information company dedicated to a transformation in cancer care in which treatment is informed by a deep understanding of the genomic changes that contribute to each patient’s unique cancer. The company offers a full suite of comprehensive genomic profiling assays to identify the molecular alterations in a patient’s cancer and match them with relevant targeted therapies, immunotherapies and clinical trials.

Foundation Medicine’s molecular information platform aims to improve day-to-day care for patients by serving the needs of clinicians, academic researchers and drug developers to help advance the science of molecular medicine in cancer.

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FoundationOne CDx detects tumor BRCA1 and BRCA2 mutations including both germline (inherited) and somatic (acquired) mutations. FoundationOne CDx may help identify more women who could benefit from the PARP inhibitor marketed as 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 of 2018, AstraZeneca and Merck & Co., Inc. announced that the FDA approved Lynparza for use as maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated (gBRCAm or sBRCAm) 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.

“Foundation Medicine is proud to receive FDA approval for another important companion diagnostic on FoundationOne CDx, our broad companion diagnostic test that is clinically and analytically validated for all solid tumors.” … “It is imperative that women with advanced ovarian cancer receive rigorous testing for BRCA1/2 mutations such as FoundationOne CDx, which includes both germline and somatic mutations, to determine if they are a candidate for PARP inhibitors.” – Brian Alexander, M.D., M.P.H., Chief Medical Officer, Foundation Medicine