{"entity":{"id":"kras-g12d","kind":"biomarker","name":"KRAS G12D (and other non-G12C KRAS mutations)","aka":["KRAS G12D","G12D","KRAS G12V","KRAS G13D","KRAS mutant","KRAS codon 12 mutation","KRAS wild-type","RAS wild-type"],"tldr":"G12D is the commonest KRAS mutation, especially in pancreatic cancer, and has no approved drug yet. In bowel cancer any KRAS or NRAS mutation is a reason not to give EGFR antibodies, which is where the approvals sit.","summary":"KRAS G12D (c.35G>A) drives about 40 percent of pancreatic and 12 percent of colorectal cancers; G12V and G13D follow. No G12D-selective drug is approved: zoldonrasib (RMC-9805) and the pan-RAS(ON) inhibitor daraxonrasib are in trials (RASolute 302, NCT06625320, is the phase 3 in pancreatic cancer). The approvals that turn on non-G12C KRAS status are negative ones: cetuximab and panitumumab are labelled for KRAS wild-type (and RAS wild-type) metastatic colorectal cancer, with the therascreen KRAS RGQ PCR Kit, cobas KRAS test, FoundationOne CDx and Tempus xT CDx listed as companion diagnostics for detecting the absence of codon 12 and 13 mutations.","asOf":"2026-09-23","links":[{"label":"FDA: List of FDA-Authorized Companion Diagnostic Devices","url":"https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-in-vitro-and-imaging-tools"}],"tags":["biomarker","kras"],"related":["kras-g12c"],"cancers":["pancreatic","colorectal","nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["cetuximab","panitumumab","therascreen-cdx"],"companies":[],"institutions":[],"pathways":[],"terms":["kras-mutation-subtypes","wild-type"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"target":"kras","measurement":"sequencing-variant","scoringRule":{"text":"Presence of a KRAS codon 12 or 13 (or exon 3 and 4) mutation other than G12C by PCR or sequencing; for EGFR antibodies the selecting result is the absence of KRAS and NRAS mutations in exons 2, 3 and 4.","quote":"KRAS wild-type (absence of mutations in codons 12 and 13)","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 wild-type (negative selector)","drugId":"cetuximab","cancerId":"colorectal","regulator":"FDA","source":"https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-in-vitro-and-imaging-tools","quote":"KRAS wild-type (absence of mutations in codons 12 and 13)","status":"current","note":"FDA companion diagnostic row for the therascreen KRAS RGQ PCR Kit with Erbitux, P110030 (06 July 2012)."},{"value":"KRAS and NRAS wild-type (negative selector)","drugId":"panitumumab","cancerId":"colorectal","regulator":"FDA","source":"https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-in-vitro-and-imaging-tools","quote":"KRAS wild-type (absence of mutations in exons 2, 3, or 4) and NRAS wild-type (absence of mutations in exons 2, 3, or 4)","status":"current","note":"FDA companion diagnostic rows for FoundationOne CDx and xT CDx with Vectibix."}],"definedBy":{"label":"RASolute 302: daraxonrasib versus chemotherapy in previously treated metastatic pancreatic cancer (ClinicalTrials.gov NCT06625320)","url":"https://clinicaltrials.gov/study/NCT06625320"},"tests":["foundationone-cdx","tempus-xt","guardant360-cdx","caris-mi-cancer-seek"],"assays":["kras-therascreen","foundationone-cdx-panel"],"companionDiagnostics":[{"device":"therascreen KRAS RGQ PCR Kit","maker":"QIAGEN Manchester","companyId":"qiagen","drugs":["cetuximab"],"indication":"Colorectal Cancer - Tissue","pma":"P110030 (07/06/2012)","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":["panitumumab"],"indication":"Colorectal Cancer - Tissue","pma":"P110027 (05/23/2014)","source":"https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-in-vitro-and-imaging-tools"},{"device":"FoundationOne CDx","maker":"Foundation Medicine","companyId":"foundation-medicine","drugs":["panitumumab"],"indication":"Colorectal Cancer - Tissue (KRAS and NRAS wild-type)","pma":"P170019 (11/30/2017)","source":"https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-in-vitro-and-imaging-tools"}],"forPatient":"A KRAS G12D, G12V or G13D result does not yet open a targeted tablet outside a trial, and in bowel cancer it means the EGFR antibodies cetuximab and panitumumab should not be used. In pancreatic cancer, trials of RAS inhibitors are recruiting and are worth asking about. Only a KRAS G12C result qualifies for the approved KRAS drugs."},"route":"/biomarkers/kras-g12d/","neighbours":{"biomarker":[{"id":"kras-g12c","kind":"biomarker","name":"KRAS G12C","route":"/biomarkers/kras-g12c/"}],"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":"cetuximab","kind":"drug","name":"Cetuximab","route":"/drugs/cetuximab/"},{"id":"panitumumab","kind":"drug","name":"Panitumumab","route":"/drugs/panitumumab/"},{"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":"wild-type","kind":"term","name":"Wild-type (WT)","route":"/terms/wild-type/"}],"target":[{"id":"kras","kind":"target","name":"KRAS","route":"/targets/kras/"}]}}