FoundationOne Liquid CDx Granted New and Expanded FDA Indications in Various Solid Tumors


The FDA has granted approval to the FoundationOne Liquid CDx as a companion diagnostic indicated for the to identify patients who may derive benefit from treatment with 3 FDA-approved targeted therapies, including alpelisib, rucaparib, and alectinib.

The FDA has granted approval to the FoundationOne®Liquid CDx as a companion diagnostic indicated for the to identify patients who may derive benefit from treatment with 3 FDA-approved targeted therapies, including alpelisib (Piqray), rucaparib (Rubraca), and alectinib (Alecensa).1

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

“FoundationOne Liquid CDx offers oncologists an important and minimally invasive tool to consider when making treatment decisions for their patients, regardless of the type of cancer they have,” said Brian Alexander, MD, MPH, chief medical officer at Foundation Medicine, in a statement.

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. This agent was approved for this indication based on data from the phase 3 SOLAR-1 clinical trial (NCT02437318).2

The FDA approval for rucaparib was granted in December 2016 as treatment of patients with deleterious BRCA-mutated advanced ovarian cancer who have received at least 2 prior lines of chemotherapy. The approval of the Biologic License Application for rucaparib under this indication was supported by findings from 2 multicenter, single-arm, open label clinical trials of rucaparib in 106 patients with advanced ovarian cancer. One study was a phase 1/2 study (NCT01482715), and the other was the phase 2 ARIEL2 study (NCT01891344).In these studies, FoundationFocus CDxBRCA test was utilized to determine to verify presence of BRCA mutations.3

Alectinib received FDA approval in November 2017 for the treatment of patients with ALK-positive metastatic non–small cell lung cancer (NSCLC), as detected by an FDA-approved test. This approval was based on data from the phase 3 ALEX clinical trial (NCT02075840) of alectinib plus crizotinib (Xalkori) in patients with ALK-positive NSCLC who had not received prior systemic therapy for metastatic disease.4

Based on the indications of these FDA-approved targeted therapies, FoundationOne Liquid CDx is now expanded to include detection of women or men with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (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 FoundationOne Liquid CDx is expanded to include the detection of patients with ALK-positive metastatic NSCLC who could benefit from treatment with alectinib.1

These 3 additional companion diagnostic claims expand the test’s clinical utility into breast and ovarian cancer, demonstrating our commitment to bringing precision medicine to more patients, and we plan to continue working with our biopharma partners to increase that reach,” said Alexander in a statement.

FoundationOne 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 an integrated report that shows alteration in patients and the match FDA-approved therapies to target these alterations.

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.


1. FDA approves new FoundationOne®Liquid CDx companion diagnostic indications for three targeted therapies that treat advanced ovarian, breast and non-small cell lung cancer. News release. Foundation Medicine, Inc. October 27, 2020. Accessed October 28, 2020.

2. FDA approves alpelisib for metastatic breast cancer. News release. FDA. May 24, 2019. Accessed October 28, 2020.

3. FDA grants accelerated approval to new treatment for advanced ovarian cancer. News release. FDA. December 19, 2016. Accessed October 28, 2020.

4. Alectinib approved for (ALK) positive metastatic non-small cell lung cancer (NSCLC). News release. FDA, November 6, 2017. Accessed October 28. 2020.

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