FDA Approves FoundationOne CDx for Use With Entrectinib For NSCLC, Solid Tumors


Treatment identifies patients with ROS1 fusion-positive non-small cell lung cancer or those with NTRK fusion-positive solid tumors for whom treatment with Rozlytrek may be appropriate.

The FDA has approved FoundationOne CDx (Foundation Medicine) as a companion diagnostic (CDx) forentrectinib (Rozlytrek; Roche), according to a statement from Roche.

FoundationOne CDx is a comprehensive genomic profiling (CGP) pan-tumor tissue biopsy test that assesses an individual’s cancer to identify the unique molecular fingerprint of the tumor. It is the first and only FDA-approved CDx to identify individuals with ROS1 fusion-positive non–small cell lung cancer (NSCLC) or individuals with NTRK fusion-positive cancers, for whom treatment with entrectinib may be appropriate.

“The ability to tailor cancer therapies based on specific genomic alterations using validated CGP has transformed the traditional ‘one-size fits-all’ approach to cancer,” Levi Garraway, MD, PhD, CEO and head of Global Product Development at Roche, said in the statement. “This approval marks a significant step forward in expanding treatment options and improving outcomes for patients, particularly those with rare tumors.”

Using CGP to identify the genomic alterations that are associated with driving an individual’s cancer can support physicians in making informed treatment decisions, potentially achieving better clinical outcomes.

Entrectinib is a targeted therapy approved to treat ROS1 fusion-positive metastatic NSCLC and a tumor-agnostic medicine for locally advanced or solid tumors that harbor NTRK fusions.

ROS1 gene fusions account for 1% to 2% of NSCLC, which is the most common type of lung cancer comprising up to 85% of all diagnoses, according to the statement.

NTRK gene fusions have been identified in a range of solid tumor types and are present in up to 90% of some rare cancer types and less than 1% of other more common cancers, including colorectal and lung cancers, according to the statement.

The approval of FoundationOne is based on data from the phase 1 ALKA-372-001, phase 1 STARTRK-1, and phase 2 STARTRK-2 trials.

As a condition of the approval, Foundation medicine will conduct a post-approval study, powered by Flatiron Health-Foundation Medicine’s Clinico-Genomic Database (CGDB), to further demonstrate FoundationOne CDx’s ability to identify individuals with ROS1 fusion-mutated NSCLC for whom treatment with entrectinib may be appropriate.

The CGDB is a de-identified, Health Insurance Portability and Accountability Act of 1996-compliant database that links outcomes data from Flatiron’s network of oncology clinics and genomic data from Foundation Medicine’s CGP assays. The database contains more than 100,000 linked genomic profiles and is continually growing.

FoundationOne CDx is a next-generation sequencing-based in vitro diagnostic assay for detection of substitution, insertion, deletion alteration, and copy number alteration 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.

Entrectinib is a tumor-agnostic once-a-day oral medication for the treatment of locally advanced or metastatic solid tumors that harbor NTRK 1/2/3 or ROS1 gene fusions. It is a selective tyrosine kinase inhibitor designed to inhibit the kinase activity of the TRKA/B/C and ROS1 proteins, whose activating fusions drive proliferation in certain types of cancer.


U.S. FDA approves Foundation Medicine’s FoundationOne CDx as a companion diagnostic for Roche’s Rozlytrek (entrectinib). Roche. News release. June 9, 2022. Accessed June 10, 2022. https://www.roche.com/media/releases/med-cor-2022-06-09b

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