- FoundationOne CDx can now be used to identify patients with ROS1 fusion-positive non-small cell lung cancer or patients with NTRK fusion-positive solid tumours for whom treatment with Rozlytrek may be appropriate
- This approval marks the first and only companion diagnostic indication for Rozlytrek, and another important milestone in tumour-agnostic approaches for people living with rare cancers
- Roche is a leader in driving personalised healthcare around the world through validated diagnostic tools, genomic insights and a continued focus on drug development
Basel, 9 June 2022 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the United States Food and Drug Administration (U.S. 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 cancers, for whom treatment with Rozlytrek may be appropriate.
“The ability to tailor cancer therapies based on specific genomic alterations using validated comprehensive genomic profiling (CGP) has transformed the traditional ‘one-size fits-all’ approach to cancer,” said Levi Garraway, M.D.,…
