{"entity":{"id":"kras-g12c","kind":"biomarker","name":"KRAS G12C","aka":["KRAS G12C","G12C","KRAS p.G12C","KRAS c.34G>T","KRAS G12C-mutated"],"tldr":"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.","summary":"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.","asOf":"2026-09-23","links":[{"label":"LUMAKRAS prescribing information (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c80a362c-7ac3-4894-a076-0691e68ef8c1"},{"label":"KRAZATI prescribing information (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0b8bf078-34c2-4f45-9012-38a8ac082b01"}],"tags":["biomarker","kras"],"related":["kras-g12d","braf-v600e"],"cancers":["nsclc","colorectal","pancreatic"],"sections":[],"technologies":[],"targets":[],"drugs":["sotorasib","adagrasib","divarasib","olomorasib","panitumumab","cetuximab","therascreen-cdx","guardant360-cdx"],"companies":[],"institutions":[],"pathways":[],"terms":["kras-mutation-subtypes","ngs"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"target":"kras","measurement":"sequencing-variant","scoringRule":{"text":"The KRAS c.34G>T (p.G12C) substitution detected in tumour tissue or plasma by PCR or sequencing.","quote":"KRAS: KRAS G12C (therascreen KRAS RGQ PCR Kit, Guardant360 CDx, Agilent Resolution ctDx FIRST)","source":"https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-in-vitro-and-imaging-tools","sourceLabel":"FDA: List of FDA-Authorized Companion Diagnostic Devices"},"thresholds":[{"value":"KRAS G12C","drugId":"sotorasib","cancerId":"nsclc","regulator":"FDA","source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c80a362c-7ac3-4894-a076-0691e68ef8c1","quote":"As a single agent, for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC, as determined by an FDA-approved test, who have received at least one prior systemic therapy.","status":"current"},{"value":"KRAS G12C","drugId":"sotorasib","cancerId":"colorectal","regulator":"FDA","source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c80a362c-7ac3-4894-a076-0691e68ef8c1","quote":"LUMAKRAS, in combination with panitumumab, is indicated for the treatment of adult patients with KRAS G12C -mutated metastatic colorectal cancer (mCRC), as determined by an FDA-approved test","status":"current"},{"value":"KRAS G12C","drugId":"adagrasib","cancerId":"nsclc","regulator":"FDA","source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0b8bf078-34c2-4f45-9012-38a8ac082b01","quote":"As a single agent, for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC, as determined by an FDA-approved test, who have received at least one prior systemic therapy.","status":"current"},{"value":"KRAS G12C","drugId":"adagrasib","cancerId":"colorectal","regulator":"FDA","source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0b8bf078-34c2-4f45-9012-38a8ac082b01","quote":"KRAZATI in combination with cetuximab is indicated for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic colorectal cancer (CRC), as determined by an FDA-approved test","status":"current"}],"tests":["foundationone-cdx","foundationone-liquid-cdx","guardant360-cdx","tempus-xt","trusight-oncology-comprehensive","caris-mi-cancer-seek"],"assays":["kras-therascreen","guardant360-cdx","resolution-ctdx-first"],"companionDiagnostics":[{"device":"therascreen KRAS RGQ PCR Kit","maker":"QIAGEN Manchester","companyId":"qiagen","drugs":["sotorasib"],"indication":"Non-Small Cell Lung Cancer (NSCLC) - Tissue","pma":"P110027/S012 (05/28/2021)","source":"https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-in-vitro-and-imaging-tools"},{"device":"therascreen KRAS RGQ PCR Kit","maker":"QIAGEN Manchester","companyId":"qiagen","drugs":["adagrasib"],"indication":"Non-Small Cell Lung Cancer (NSCLC) - Tissue","pma":"P110027/S013 (12/02/2022)","source":"https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-in-vitro-and-imaging-tools"},{"device":"therascreen KRAS RGQ PCR Kit","maker":"QIAGEN Manchester","companyId":"qiagen","drugs":["adagrasib","cetuximab"],"indication":"Colorectal Cancer - Tissue","pma":"P110027/S017 (06/21/2024)","source":"https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-in-vitro-and-imaging-tools"},{"device":"therascreen KRAS RGQ PCR Kit","maker":"QIAGEN Manchester","companyId":"qiagen","drugs":["sotorasib","panitumumab"],"indication":"Colorectal Cancer - Tissue","pma":"P110027/S018 (01/16/2025)","source":"https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-in-vitro-and-imaging-tools"},{"device":"Guardant360 CDx","maker":"Guardant Health","companyId":"guardant-health","drugs":["sotorasib"],"indication":"Non-Small Cell Lung Cancer (NSCLC) - Plasma","pma":"P200010/S002 (05/28/2021)","source":"https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-in-vitro-and-imaging-tools"},{"device":"Agilent Resolution ctDx FIRST assay","maker":"Resolution Bioscience (Agilent)","companyId":"agilent","drugs":["adagrasib"],"indication":"Non-Small Cell Lung Cancer (NSCLC) - Plasma","pma":"P210040 (12/12/2022)","source":"https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-in-vitro-and-imaging-tools"}],"forPatient":"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."},"route":"/biomarkers/kras-g12c/","neighbours":{"biomarker":[{"id":"braf-v600e","kind":"biomarker","name":"BRAF V600E (and V600K)","route":"/biomarkers/braf-v600e/"},{"id":"kras-g12d","kind":"biomarker","name":"KRAS G12D (and other non-G12C KRAS mutations)","route":"/biomarkers/kras-g12d/"}],"cancer":[{"id":"colorectal","kind":"cancer","name":"Colorectal cancer","route":"/cancers/colorectal/"},{"id":"nsclc","kind":"cancer","name":"Non-small-cell lung cancer","route":"/cancers/nsclc/"},{"id":"pancreatic","kind":"cancer","name":"Pancreatic ductal adenocarcinoma","route":"/cancers/pancreatic/"}],"drug":[{"id":"adagrasib","kind":"drug","name":"Adagrasib","route":"/drugs/adagrasib/"},{"id":"cetuximab","kind":"drug","name":"Cetuximab","route":"/drugs/cetuximab/"},{"id":"divarasib","kind":"drug","name":"Divarasib","route":"/drugs/divarasib/"},{"id":"guardant360-cdx","kind":"drug","name":"Guardant360 CDx","route":"/drugs/guardant360-cdx/"},{"id":"olomorasib","kind":"drug","name":"Olomorasib","route":"/drugs/olomorasib/"},{"id":"panitumumab","kind":"drug","name":"Panitumumab","route":"/drugs/panitumumab/"},{"id":"sotorasib","kind":"drug","name":"Sotorasib","route":"/drugs/sotorasib/"},{"id":"therascreen-cdx","kind":"drug","name":"therascreen companion diagnostic kits (KRAS, EGFR, PIK3CA, FGFR, BRAF)","route":"/drugs/therascreen-cdx/"}],"term":[{"id":"kras-mutation-subtypes","kind":"term","name":"KRAS mutation subtypes (G12C, G12D, G12V)","route":"/terms/kras-mutation-subtypes/"},{"id":"ngs","kind":"term","name":"Next-generation sequencing (NGS)","route":"/terms/ngs/"}],"target":[{"id":"kras","kind":"target","name":"KRAS","route":"/targets/kras/"}]}}