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A ROS1 fusion drives about 1 to 2 percent of lung adenocarcinomas and behaves much like ALK. Crizotinib, entrectinib, repotrectinib and taletrectinib are approved for it.
ROS1 rearrangements (partners include CD74, SLC34A2 and EZR) are detected by FISH, IHC or sequencing; the FDA list carries the Oncomine Dx Target Test for crizotinib and FoundationOne CDx and Liquid CDx for entrectinib. Crizotinib was the first drug labelled for ROS1-positive metastatic NSCLC (2016); entrectinib (2019) and repotrectinib (2023) followed, the latter with activity after prior ROS1 inhibitors and against the G2032R solvent-front mutation; taletrectinib (Ibtrozi, 2025) is labelled for locally advanced or metastatic ROS1-positive NSCLC without a named test requirement.
In plain words · A gene fusion in about 1-2% of lung cancers that responds for years to targeted pills, now in their third generation.
A ROS1 fusion means a ROS1 tablet (repotrectinib, taletrectinib, entrectinib or crizotinib) is the first treatment for advanced lung cancer, with the newer drugs preferred where brain spread is a concern. If the tumour later grows, a second ROS1 inhibitor may still work depending on the resistance mutation found.
Written only from the label or guideline text cited on this page. Not medical advice; your own report and the reading your team gives it come first.
A ROS1 gene fusion or rearrangement by FISH, immunohistochemistry confirmed by a molecular method, or DNA or RNA sequencing of tissue or plasma.
“ROS1 fusions”
FDA: List of FDA-Authorized Companion Diagnostic Devices| Threshold | Drug | Cancer | Regulator | Source |
|---|---|---|---|---|
| ROS1-positive | Entrectinib | Non-small-cell lung cancer | FDA | label |
| ROS1-positive | Repotrectinib | Non-small-cell lung cancer | FDA | label |
| ROS1-positive | Taletrectinib | Non-small-cell lung cancer | FDA | label |
| ALK or ROS1-positive | Crizotinib | Non-small-cell lung cancer | FDA | label |
| Device | Maker | Indication and sample | Drug | PMA / 510(k) |
|---|---|---|---|---|
| Oncomine Dx Target Test | Life Technologies (Thermo Fisher Scientific) | Non-Small Cell Lung Cancer (NSCLC) - Tissue | Crizotinib | P160045 (06/22/2017) |
| FoundationOne CDx | Foundation Medicine | Non-Small Cell Lung Cancer (NSCLC) - Tissue | Entrectinib | P170019/S014 (06/07/2022) |
| FoundationOne Liquid CDx | Foundation Medicine | Non-Small Cell Lung Cancer (NSCLC) - Plasma | Entrectinib | P190032/S004 (12/22/2022) |
Matched on the name and aliases of the readout in the title, setting and summary of each trial; a match is a mention, not proof the readout was an entry criterion.
It is the document that defines what a complete lung cancer molecular report looks like, and its asymmetry about plasma, rule in but never rule out, is the single most useful sentence in it.
It defined a class of lung cancer by a rearrangement and a clinical phenotype at the same time, and it is the reason ROS1 testing is recommended for every patient with adenocarcinoma rather than only for those with an obvious risk profile.
Shares Oncomine Dx Target Test, Updated molecular testing guideline for the selection of lung cancer patients for treatment with targeted tyrosine kinase inhibitors, Non-small-cell lung cancer and the tag biomarker.
Shares Oncomine Dx Target Test, Updated molecular testing guideline for the selection of lung cancer patients for treatment with targeted tyrosine kinase inhibitors, FoundationOne CDx / Liquid CDx, Non-small-cell lung cancer and the tag biomarker.
Shares Oncomine Dx Target Test, NRG1 gene fusion, Non-small-cell lung cancer and the tag biomarker.
Shares ALK fusion (ALK-positive), Gene fusion, Non-small-cell lung cancer and the tag biomarker.
Shares Updated molecular testing guideline for the selection of lung cancer patients for treatment with targeted tyrosine kinase inhibitors, FoundationOne CDx / Liquid CDx, Non-small-cell lung cancer and the tag biomarker.
Shares Repotrectinib, ROS1, Tyrosine kinase inhibitor (TKI), Entrectinib.
Shares FoundationOne CDx / Liquid CDx, Gene fusion and the tag biomarker.
Shares FoundationOne CDx / Liquid CDx, Gene fusion and the tag biomarker.