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RET fusions drive 1 to 2 percent of lung cancers and some thyroid cancers; RET point mutations drive medullary thyroid cancer. Selpercatinib is approved for RET fusions in any solid tumour and for RET-mutant medullary thyroid cancer; pralsetinib for RET fusion lung cancer.
RET fusions (KIF5B::RET, CCDC6::RET, NCOA4::RET) are detected by RNA or DNA sequencing and FISH; RET point mutations (M918T, codon 634 and others, germline in MEN2) by sequencing. Selpercatinib (Retevmo) is labelled for RET fusion-positive NSCLC, RET fusion-positive thyroid cancer, RET-mutant medullary thyroid cancer and, since 2022, RET fusion-positive solid tumours after prior therapy, each as detected by an FDA-approved test; pralsetinib (Gavreto) for RET fusion-positive NSCLC. The Oncomine Dx Target Test, FoundationOne CDx and TruSight Oncology Comprehensive are the listed companion diagnostics.
In plain words · RET is a kinase altered in thyroid cancer and a small slice of lung cancer, treatable with one selective pill regardless of where the tumour is.
A RET fusion means selpercatinib (or, in lung cancer, pralsetinib) is an on-label tablet whatever the cancer type once other treatment has been tried, and first line in lung cancer. In medullary thyroid cancer a RET point mutation qualifies for selpercatinib too, and if the mutation is inherited (MEN2) relatives should be tested.
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 RET gene fusion by RNA or DNA sequencing (or FISH), or an activating RET point mutation, small deletion or insertion by sequencing.
“RET fusions; RET mutations (SNVs, MNVs, and deletions)”
FDA: List of FDA-Authorized Companion Diagnostic Devices| Threshold | Drug | Cancer | Regulator | Source |
|---|---|---|---|---|
| RET fusion-positive | Pralsetinib | Non-small-cell lung cancer | FDA | label |
| RET fusion-positive (NSCLC, thyroid, solid tumours) and RET-mutant medullary thyroid cancer Retevmo label indications 1.1 to 1.4 (DailyMed set id 7fa848ba): RET fusion-positive NSCLC, RET-mutant medullary thyroid cancer, RET fusion-positive thyroid cancer, and RET fusion-positive solid tumours after prior systemic treatment, each as detected by an FDA-approved test. | Selpercatinib | Medullary thyroid cancer | FDA | label |
| RET fusion-positive FDA companion diagnostic rows for the Oncomine Dx Target Test (P160045/S031) and TruSight Oncology Comprehensive (P230011) with Retevmo in NSCLC. | Selpercatinib | 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 | Pralsetinib | P160045/S019 (09/04/2020) |
| Oncomine Dx Target Test | Life Technologies (Thermo Fisher Scientific) | Medullary Thyroid Cancer (MTC) - Tissue | Selpercatinib | P160045/S031 (09/21/2022) |
| FoundationOne CDx | Foundation Medicine | Solid Tumors - Tissue | Selpercatinib | P170019/S043 (10/06/2023) |
| TruSight Oncology Comprehensive | Illumina | Non-Small Cell Lung Cancer (NSCLC) - Tissue | Selpercatinib | P230011 (08/21/2024) |
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.
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 FoundationOne CDx / Liquid CDx, Gene fusion and the tag biomarker.
Shares FoundationOne CDx / Liquid CDx, Tumour-agnostic (tissue-agnostic) approval, Metastatic cancer (cancer that has spread), Colorectal cancer and the tag biomarker.
Shares Tumour-agnostic (tissue-agnostic) approval, Thyroid cancer, Metastatic cancer (cancer that has spread), Colorectal cancer and the tag biomarker.