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Foundation Medicine’s Liquid Biopsy Test Bags FDA Approval for Eighth Indication as Companion Diagnostic
On November 9th, FoundationOne Liquid CDx, a sequencing-based assay of cell-free tumor DNA, from Foundation Medicine received the FDA approval for use as a companion diagnostic for patients with metastatic castration-resistant prostate cancer (mCRPC) who are eligible for treatment with Lynparza (olaparib).
FoundationOne Liquid CDx identifies mutations in BRCA1, BRCA2, and/or ATM genes in mCRPC patient’s blood who may be candidates for treatment with the PARP inhibitor.
Foundation Medicine offers comprehensive genomic profiling (CGP) assays to identify a diverse range of molecular alterations in the patient’s tumor samples and match them with relevant, targeted therapies, immunotherapies, and clinical trials. FoundationOne Liquid CDx is the company’s blood-based CGP tool that analyzes short variants in over 300 cancer-related genes, including mutations in homologous recombination repair (HRR) genes such as BRCA1 and BRCA2, in circulating cell-free DNA and subsequently helps match the mutations for specific FDA-approved therapies. With the latest approval, Foundation Medicine’s CGP is now approved as a companion diagnostic for several indications across four tumor types.
In August 2020, the FDA had approved this liquid biopsy test for all solid tumors with multiple indications. As a companion diagnostic, the assay identifies eligible patients harboring BRCA1/2 mutations who can receive Rubraca for their mCRPC and 3 first-line EGFR-TKIs for NSCLC.
The approval was based on analytical and clinical validation studies that collected more than 7500 samples and 30,000 unique variants across over 30 cancer types. Upon evaluating the platform across these diverse tumor types, the test demonstrated high sensitivity and specificity, even at the low allele frequencies that the collected blood samples provided.
Shortly after, in late October, FoundationOne Liquid CDx landed additional FDA approvals for use as a companion diagnostic for three indications:
- Patients with ovarian cancer harboring BRCA1 and BRCA2 mutations, eligible for treatment with Rubraca (rucaparib);
- Patients with non-small cell lung cancer (NSCLC) having ALK rearrangements, eligible for treatment with Alecensa (alectinib); and
- Patients with breast cancer having PIK3CA mutations, eligible for treatment with Piqray (alpelisib).
“With this latest companion diagnostic approval, physicians now have the option to choose either tissue or liquid-based comprehensive genomic testing based on their patients’ need and condition,” said Brian Alexander, M.D., M.P.H., chief medical officer at Foundation Medicine, in an accompany-issued press release.
“Since tissue availability can be an issue for some metastatic prostate cancer patients, blood-based testing is an important option to consider and critically important for informing patient care.”
Lynparza is an FDA approved treatment for mCRPC patients who harbor mutations in HRR genes and who progressed on previous treatment with either Xtandi or Zytiga. Data from the phase III PROfound trail, based on which the AstraZeneca drug received approval, demonstrated a reduced risk of disease progression compared with either drug. Lynparza also improved the overall survival of BRCA1/2 or ATM altered mCRPC patients.
In May 2020, the tissue-based CGP, FoundationOne CDx, was approved for use as a companion diagnostic for Lynparza.
By Sangeeta Chakraborty, Ph.D.
Related Article: FMI’s Liquid Biopsy Test Adds 3 Companion Diagnostic Indications for Advanced Ovarian, Breast, and Lung Cancers
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