FDA approves FoundationOne CDx as companion diagnostic for Rozlytrek in solid tumours.
Roche announced that the FDA has approved Foundation Medicine’s FoundationOne CDx as a companion diagnostic (CDx) for Roche’s Rozlytrek (entrectinib).
FoundationOne CDx is a comprehensive genomic profiling (CGP) pan-tumour tissue biopsy test that assesses an individual’s cancer to identify the unique molecular ‘fingerprint’ of the tumour. It is the first and only U.S. FDA-approved CDx to identify patients with ROS1 fusion-positive non-small cell lung cancer (NSCLC), or patients with NTRK fusion-positive solid tumour cancers, for whom treatment with Rozlytrek may be appropriate.
The approval is based on data from the phase I ALKA-372-001 (EudraCT 2012-000148-88), 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 powered by the Flatiron Health-Foundation Medicine’s Clinico-Genomic Database (CGDB) to further demonstrate FoundationOne CDx’s ability to identify patients with ROS1 fusion-mutated NSCLC for whom treatment with Rozlytrek may be appropriate. 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 CGP assays. The database currently contains more than 100,000 linked genomic profiles , and is continually growing.
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