Foundation Medicine Notches Additional FDA Approvals

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The FDA has approved new indications for Foundation Medicine's liquid biopsy assay and also its tissue-based companion diagnostic for solid tumors.

The FDA has granted additional approvals to Foundation Medicine for its precision genomics assays.

This week, the FDA approved the company’s Liquid CDx as a companion diagnostic to identify patients who may benefit 3 targeted therapies, including alpelisib (Piqray), rucaparib (Rubraca), and alectinib (Alecensa).

These 3 additional companion diagnostic claims expand the test’s clinical utility into breast and ovarian cancer, the company said in a statement.

In addition, the FDA expanded the label indication for Liquid CDx as a tool to report select copy number alterations and genomic rearrangements.

Liquid CDx is a comprehensive liquid biopsy assay that profiles tumors according to the testing guidelines for the various solid tumors.The assay is able to evaluate more than 300 cancer-related gene for genomic alteration. Results from testing with FoundationOne Liquid CDx are provided in a report that shows alteration in patients and the matched FDA-approved therapies to target these alterations.

Alpelisib was granted approval by the FDA in May 2019 for the treatment of postmenopausal women and men with hormone receptor (HR)-positive, HER2-negative, PIK3CA-mutated, advanced or metastatic breast cancer following progression on or after treatment with an endocrine-based regimen.

The FDA approved rucaparib in December 2016 as treatment of patients with deleterious BRCA-mutated advanced ovarian cancer. Alectinib was approved in November 2017 for the treatment of patients with ALK-positive metastatic non–small cell lung cancer (NSCLC).

Based on the indications of these FDA-approved targeted therapies, FoundationOne Liquid CDx is now expanded to include detection of women or men with HR-positive, HER2-negative, PIK3CA mutated, advanced or metastatic breast cancer following progression on or after an endocrine-based regimen who may benefit from the combination of alpelisib and fulvestrant. The assay is also expanded for use as an identifier of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more chemotherapy agents who may derive benefit from rucaparib.


Finally, the indication for Liquid CDx is expanded to include the detection of patients with ALK-positive metastatic NSCLC who could benefit from treatment with alectinib.

In addition to its expanded indications, the assay was granted approval as a companion diagnostic to assist in identifying patients with metastatic castration-resistant prostate cancer patients with qualifying BRCA1/2 alterations who may derive benefit from an FDA-approved PARP inhibitor, and to identify those with NSCLC who may do well on treatment with an EGFR tyrosine kinase inhibitor.

In addition, last week the FDA gave approval to the company’s CDx as a companion diagnostic for the identification of NTRK fusions across all solid tumors that can be targeted by larotrectinib (Vitrakvi).

CDx is a tissue-based comprehensive genomic profiling test approved for the detection of NTRK1/2/3 fusions across all solid tumors; it is currently approved as a companion diagnostic for over 20 different targeted therapies.

Larotrectinib is approved for the treatment of adult and pediatric patients with solid tumors harboring an NTRK fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to cause severe disease or have progressed following prior treatment.

FoundationOne CDx can detect substations, insertion or deletion alterations, and copy number alterations in 324 genes and select gene rearrangements, and it can also detect genomic signatures including microsatellite instability and tumor mutational burden by using DNA isolated from formalin-fixed paraffin embedded tumor tissue specimens.