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KRAS G12C swaps glycine 12 for cysteine and was the first KRAS mutation a drug could grip. Sotorasib and adagrasib are approved for it in lung cancer, and with an EGFR antibody in bowel cancer.
The c.34G>T (G12C) substitution is found in about 13 percent of lung adenocarcinomas and 3 to 4 percent of colorectal cancers. Sotorasib and adagrasib are labelled as single agents for KRAS G12C-mutated locally advanced or metastatic NSCLC after at least one prior systemic therapy, and in colorectal cancer sotorasib with panitumumab and adagrasib with cetuximab after prior chemotherapy, each 'as determined by an FDA-approved test'. The therascreen KRAS RGQ PCR Kit, Guardant360 CDx, Agilent Resolution ctDx FIRST and FoundationOne CDx carry the claims. G12C is the only KRAS mutation with an approved drug; the other codon 12 and 13 mutations are used as negative selectors for EGFR antibodies in colorectal cancer.
In plain words · KRAS is the most commonly mutated cancer gene, called 'undruggable' for 40 years until 2021.
KRAS G12C is the one KRAS change with approved tablets. In lung cancer sotorasib or adagrasib are on label after a first treatment; in bowel cancer they are given with an EGFR antibody after chemotherapy. Other KRAS mutations (G12D, G12V) do not qualify for these drugs yet, so the exact letter on your report matters.
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.
The KRAS c.34G>T (p.G12C) substitution detected in tumour tissue or plasma by PCR or sequencing.
“KRAS: KRAS G12C (therascreen KRAS RGQ PCR Kit, Guardant360 CDx, Agilent Resolution ctDx FIRST)”
FDA: List of FDA-Authorized Companion Diagnostic Devices| Threshold | Drug | Cancer | Regulator | Source |
|---|---|---|---|---|
| KRAS G12C | Sotorasib | Non-small-cell lung cancer | FDA | label |
| KRAS G12C | Sotorasib | Colorectal cancer | FDA | label |
| KRAS G12C | Adagrasib | Non-small-cell lung cancer | FDA | label |
| KRAS G12C | Adagrasib | Colorectal cancer | FDA | label |
| Device | Maker | Indication and sample | Drug | PMA / 510(k) |
|---|---|---|---|---|
| therascreen KRAS RGQ PCR Kit | QIAGEN Manchester | Non-Small Cell Lung Cancer (NSCLC) - Tissue | Sotorasib | P110027/S012 (05/28/2021) |
| therascreen KRAS RGQ PCR Kit | QIAGEN Manchester | Non-Small Cell Lung Cancer (NSCLC) - Tissue | Adagrasib | P110027/S013 (12/02/2022) |
| therascreen KRAS RGQ PCR Kit | QIAGEN Manchester | Colorectal Cancer - Tissue | AdagrasibCetuximab | P110027/S017 (06/21/2024) |
| therascreen KRAS RGQ PCR Kit | QIAGEN Manchester | Colorectal Cancer - Tissue | SotorasibPanitumumab | P110027/S018 (01/16/2025) |
| Guardant360 CDx | Guardant Health | Non-Small Cell Lung Cancer (NSCLC) - Plasma | Sotorasib | P200010/S002 (05/28/2021) |
| Agilent Resolution ctDx FIRST assay | Resolution Bioscience (Agilent) | Non-Small Cell Lung Cancer (NSCLC) - Plasma | Adagrasib | P210040 (12/12/2022) |
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.
One of the most cited trial reports Europe PMC returns for Daraxonrasib in Pancreatic ductal adenocarcinoma, so it is a natural first reading for anyone weighing the idea it is linked from. The record was linked automatically by title and abstract; read the abstract above and the paper itself before relying on any figure.
Sotorasib is a guideline-listed later-line option for the 1 to 2 percent of pancreatic cancers with KRAS G12C, and the proof that KRAS in pancreatic cancer is druggable; the larger opportunity lies with inhibitors of G12D and pan-RAS drugs.
Patients with metastatic colorectal cancer carrying a KRAS G12C mutation (about 3-4% of cases) who have exhausted standard chemotherapy now have a targeted option that works far better than trifluridine-tipiracil or regorafenib. The higher sotorasib dose is clearly superior, and the EGFR antibody is essential because KRAS inhibition alone has little effect in bowel cancer. Responses are still modest and short-lived compared with EGFR or ALK inhibitors in lung cancer.
Adagrasib joins sotorasib as a later-line option for KRAS G12C pancreatic cancer in guidelines; both drugs are the template for the G12D and pan-RAS inhibitors now in pancreatic trials.
Adagrasib plus cetuximab is an approved option for previously treated KRAS G12C colorectal cancer, alongside sotorasib plus panitumumab; monotherapy is not enough because EGFR signalling reactivates the pathway.
It defines the population the G12C inhibitors address and sets the baseline against which CodeBreaK 300 and KRYSTAL-1 are read.
It fixed the working numbers for a comprehensive panel in pancreatic cancer: a hit worth acting on in about one patient in six, most of it in repair genes and the KRAS wild-type minority.
One of the most cited trial reports Europe PMC returns for KRAS in Non-small-cell lung cancer, so it is a natural first reading for anyone weighing the idea it is linked from. The record was linked automatically by title and abstract; read the abstract above and the paper itself before relying on any figure.
Shares Using multiplexed assays of oncogenic drivers in lung cancers to select targeted drugs, Guardant360 CDx, Next-generation sequencing (NGS), Non-small-cell lung cancer and the tag biomarker.
Shares therascreen companion diagnostic kits (KRAS, EGFR, PIK3CA, FGFR, BRAF), Next-generation sequencing (NGS), Colorectal cancer, Non-small-cell lung cancer and the tag biomarker.
Shares therascreen companion diagnostic kits (KRAS, EGFR, PIK3CA, FGFR, BRAF), Guardant360 CDx, Next-generation sequencing (NGS), Non-small-cell lung cancer and the tag biomarker.
Shares Real-time targeted genome profile analysis of pancreatic ductal adenocarcinomas identifies genetic alterations that might be targeted with existing drugs or used as biomarkers, Next-generation sequencing (NGS), Pancreatic ductal adenocarcinoma, Colorectal cancer and the tag biomarker.
Shares Guardant360 CDx, Next-generation sequencing (NGS), Non-small-cell lung cancer and the tag biomarker.
Shares STK11 or KEAP1 loss in KRAS-mutant lung adenocarcinoma, Lung cancer (all types), Non-small-cell lung cancer and the tag biomarker.
Shares Using multiplexed assays of oncogenic drivers in lung cancers to select targeted drugs, Pancreatic ductal adenocarcinoma, Non-small-cell lung cancer and the tag biomarker.
Shares Adagrasib, Sotorasib, KRAS, Non-small-cell lung cancer and the tag kras.