On June 9, Foundation Medicine, Inc., announced that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOne CDx to be used as a companion diagnostic for the two indications of the tyrosine kinase inhibitor entrectinib (Rozlytrek). As a companion diagnostic, FoundationOne CDx can be used to identify patients with ROS1-positive non–small cell lung cancer (NSCLC), or patients with NTRK fusion–positive solid tumors who may be appropriate for treatment with entrectinib.
“Comprehensive and validated genomic testing is critical to identify patients with ROS1 or NTRK gene fusions, as they are rare and can be missed when more limited or unvalidated testing panels are used to profile a patient’s tumor,” said Mia Levy, MD, PhD, Chief Medical Officer at Foundation Medicine. “We’re proud that this companion diagnostic will enable broader access to genomic testing and this breakthrough therapy, ultimately allowing more patients to benefit from precision medicine.”
As a condition of this approval, Foundation Medicine will conduct a post-approval study powered by the Flatiron Health-Foundation Medicine Clinico-Genomic Database (CGDB) to further demonstrate FoundationOne CDx’s ability to identify patients with NSCLC and ROS1 fusions who may respond to entrectinib. The CGDB is a de-identified, HIPAA-compliant database that links outcomes data from Flatiron’s network of oncology clinics and genomic data from Foundation Medicine’s comprehensive genomic profiling assays. The database currently contains more than 100,000 linked genomic profiles.
NSCLC is the most common type of lung cancer, accounting for 80% to 85% of all lung cancer diagnoses. When ROS1 gene fusions occur, generally in 1% to 2% of NSCLC diagnoses, cancer cells grow and proliferate in an uncontrolled manner. NTRK gene fusions occur when NTRK1/2/3 genes fuse with other genes, resulting in altered TRK proteins, which can activate signaling pathways involved in proliferation of certain types of cancer. Though rare, occurring in roughly 0.3% of all solid tumors, these fusions can be found in many tumor types, including breast cancer, cholangiocarcinoma, colorectal cancer, gynecologic cancers, neuroendocrine tumors, NSCLC, salivary gland cancer, pancreatic cancer, sarcoma, and thyroid cancer. Comprehensive genomic profiling is an important tool for identifying these rare mutations.
Using a tissue sample, FoundationOne CDx analyzes more than 300 cancer-related genes for genomic alterations in a patient’s tumor. The test is FDA-approved as a companion diagnostic for 25 CDx indications, and 3 group claims across 30 targeted therapies. FoundationOne CDx is also the first and only companion diagnostic approved for entrectinib.
