This site is intended for healthcare professionals
News

FDA approves FoundationOne CDx as companion diagnostic for Rozlytrek in solid tumours.

Read time: 1 mins
Published:10th Jun 2022

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.

Condition: Solid Tumours
Type: drug

Learning Zones

The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.