On June 9, 2022, Foundation Medicine announced that the U.S. Food and Drug Administration (FDA) has approved FoundationOneCDx as a companion diagnostic for two indications of Rozlytrek (entrectinib).
As a companion diagnostic, FoundationOneCDx can be used to identify patients with ROS1-positive non-small cell lung cancer (NSCLC) or patients with neurotrophic tyrosine receptor kinase (NTRK) fusion-positive solid tumors (entrectinib) who may be suitable candidates for treatment with Rozlytrek.
Notably, FoundationOneCDx is the first and only FDA-approved companion diagnostic for Rozlytrek (entrectinib).
Rozlytrek is a targeted therapy approved for the treatment of ROS1 fusion-positive metastatic non-small cell lung cancer and is also a pan-oncology drug used to treat locally advanced or solid tumors with NTRK fusions. ROS1 gene fusions account for 1-2% of NSCLC, the most common type of lung cancer, representing 85% of all diagnoses. NTRK gene fusions have been found 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 lung and colorectal cancer.
This approval is based on data from the Phase I ALKA-372-001 (EudraCT2012-000148-88), Phase I STARTRK-1 (NCT02097810), and Phase II STARKTRK-2 (NCT02568267) trials. As a condition of this approval, Foundation Medicine will conduct a post-approval study supported by FlatironHealth-Foundation Medicine's Clinical Genome Database (CGDB) to further demonstrate FoundationOneCDx's ability to identify patients with ROS1 fusion-mutant NSCLC who may be suitable for Rozlytrek treatment.
CGDB is an unidentified, HIPAA-compliant database that links outcome data from Flatiron’s network of oncology clinics with genomic data from Foundation Medicine’s CGP analysis. The database currently contains over 100,000 interconnected genomic maps and is continuously expanding.
FoundationOneCDx is for prescription use only and is designed as a companion diagnostic to identify patients who may benefit from certain targeted therapies based on their approved therapeutic product labels.
