Foundation Medicine has secured the US Food and Drug Administration (FDA) approval for its FoundationOneCDx as a companion diagnostic (CDx) for two indications of Roche’s Rozlytrek (entrectinib).
Rozlytrek is a selective tyrosine kinase inhibitor that works to inhibit the kinase activity of the TRK A/B/C and ROS1 proteins, which drive certain types of cancers.
FoundationOne CDx is a prescription-only, next-generation sequencing (NGS) based in vitro-diagnostic device, used as a CDx to identify patients eligible for treatment with certain therapies.
With the current FDA approval, FoundationOne CDx can be now used to identify patients eligible for treatment using Rozlytrek, for two labelled indications.
The two indications include ROS1-positive non-small cell lung cancer (NSCLC), or patients with Neurotrophic Tyrosine Receptor Kinase (NTRK) fusion-positive solid tumours.
Foundation Medicine chief medical officer Mia Levy said: “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 tumour.”
Foundation Medicine will conduct a post-approval study, as a condition of the FDA approval, supported by the Flatiron Health-Foundation Medicine Clinico-Genomic Database (CGDB).
The study aims to further demonstrate FoundationOne CDx’s ability to identify NSCLC patients with ROS1 fusions who may respond to Rozlytrek.
The CGDB is an advanced database that connects outcomes data from Flatiron’s network of oncology clinics and genomic data from Foundation Medicine’s CGP assays.
FoundationOne CDx is the first and only companion diagnostic approved for Rozlytrek, said the US-based molecular insights company.
Foundation Medicine chief biopharma business officer Sanket Agrawal said: “We look forward to our ongoing partnership with Genentech and Flatiron Health as we implement this novel approach to post-approval evidence generation through our CGDB.
“This database is an invaluable asset for cancer research, especially in rare patient populations, like ROS1-mutated NSCLC.”
