[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"detail-sidebar-cat-0-en-105":3,"doc-seo-406658-105":59,"doc-detail-406658-en":130},{"code":4,"msg":5,"data":6},0,"success",[7,13,18,23,28,33,38,43,48,51,55],{"id":8,"doc_module":4,"doc_module_name":9,"category_name":10,"show_sort_weight":11,"slug":12},1,"Document","Story & Novel",90,"story-novel",{"id":14,"doc_module":4,"doc_module_name":9,"category_name":15,"show_sort_weight":16,"slug":17},2,"Literature",80,"literature",{"id":19,"doc_module":4,"doc_module_name":9,"category_name":20,"show_sort_weight":21,"slug":22},4,"Exam",70,"exam",{"id":24,"doc_module":4,"doc_module_name":9,"category_name":25,"show_sort_weight":26,"slug":27},5,"Comic",60,"comic",{"id":29,"doc_module":4,"doc_module_name":9,"category_name":30,"show_sort_weight":31,"slug":32},6,"Technology",50,"technology",{"id":34,"doc_module":4,"doc_module_name":9,"category_name":35,"show_sort_weight":36,"slug":37},7,"Healthcare",40,"healthcare",{"id":39,"doc_module":4,"doc_module_name":9,"category_name":40,"show_sort_weight":41,"slug":42},8,"Research & Report",30,"research-report",{"id":44,"doc_module":4,"doc_module_name":9,"category_name":45,"show_sort_weight":46,"slug":47},9,"Religion & Spirituality",20,"religion-spirituality",{"id":46,"doc_module":4,"doc_module_name":9,"category_name":49,"show_sort_weight":46,"slug":50},"World Cup","world-cup",{"id":52,"doc_module":4,"doc_module_name":9,"category_name":53,"show_sort_weight":52,"slug":54},10,"Lifestyle","lifestyle",{"id":56,"doc_module":4,"doc_module_name":9,"category_name":57,"show_sort_weight":24,"slug":58},19,"General","general",{"code":4,"msg":60,"data":61},"ok",{"site_id":62,"language":63,"slug":64,"title":65,"keywords":66,"description":67,"schema_data":68,"social_meta":123,"head_meta":125,"extra_data":127,"updated_unix":129},105,"en","regulatory-implications-of-ctdna-in-immuno-oncology-for-solid-tumors","Regulatory implications of ctDNA in immuno-oncology for solid tumors","","Precision oncology drives the growing use of circulating tumor DNA (ctDNA) as a minimally invasive option for cancer diagnosis and management, and as an enrichment tool in clinical trials. The US FDA has approved multiple ctDNA-based companion diagnostic assays for targeted therapies, with additional ctDNA assays under development for immuno-oncology treatments. In early-stage solid tumors, ctDNA can detect molecular residual disease (MRD) to guide adjuvant or escalated therapy and enable patient selection and stratification. Regulatory acceptance requires assay standardization, harmonization, and further clinical validation of ctDNA as a prognostic and predictive biomarker before serving as an efficacy-response biomarker.",{"@graph":69,"@context":122},[70,84,105],{"@type":71,"itemListElement":72},"BreadcrumbList",[73,77,79,82],{"item":74,"name":75,"@type":76,"position":8},"https://docshare.wps.com","Home","ListItem",{"item":78,"name":9,"@type":76,"position":14},"https://docshare.wps.com/document/",{"item":80,"name":35,"@type":76,"position":81},"https://docshare.wps.com/document/healthcare/",3,{"item":83,"name":65,"@type":76,"position":19},"https://docshare.wps.com/document/regulatory-implications-of-ctdna-in-immuno-oncology-for-solid-tumors/406658/",{"url":83,"name":65,"@type":85,"image":86,"author":91,"headline":65,"publisher":94,"fileFormat":97,"inLanguage":63,"description":67,"dateModified":98,"datePublished":99,"encodingFormat":97,"isAccessibleForFree":100,"interactionStatistic":101},"DigitalDocument",{"url":87,"@type":88,"width":89,"height":90},"https://docshare.wps.com/thumbnails/regulatory-implications-of-ctdna-in-immuno-oncology-for-solid-tumors/406658.png","ImageObject",300,407,{"name":92,"@type":93},"hdkawk","Person",{"url":74,"name":95,"@type":96},"DocShare","Organization","application/pdf","2026-10-27","2026-09-28",true,{"@type":102,"interactionType":103,"userInteractionCount":39},"InteractionCounter",{"@type":104},"ViewAction",{"@type":106,"mainEntity":107},"FAQPage",[108,114,118],{"name":109,"@type":110,"acceptedAnswer":111},"What role does ctDNA play in precision oncology and clinical trials?","Question",{"text":112,"@type":113},"ctDNA supports minimally invasive diagnosis and management, and it can enrich clinical trials by helping identify patients and stratify risk using molecular alterations and MRD signals.","Answer",{"name":115,"@type":110,"acceptedAnswer":116},"How has the US FDA used ctDNA-based assays?",{"text":117,"@type":113},"The FDA has approved multiple ctDNA-based companion diagnostic assays for targeted therapies, primarily for selection of patients for specific treatments, and additional ctDNA assays are being developed for immuno-oncology.",{"name":119,"@type":110,"acceptedAnswer":120},"Why are standardization and harmonization important for ctDNA regulatory acceptance?",{"text":121,"@type":113},"Standardization and harmonization of ctDNA assays and methodologies, along with further clinical validation, are needed so ctDNA can be accepted as a prognostic and predictive biomarker and ultimately an efficacy-response biomarker for regulatory decisions.","https://schema.org",{"og:url":83,"og:type":124,"og:title":65,"og:site_name":95,"og:description":67},"article",{"robots":126,"canonical":83},"index,follow",{"doc_id":128,"site_id":62},406658,1791290681,{"code":4,"msg":5,"data":131},{"doc_id":128,"user_id":132,"nickname":92,"user_avatar":133,"doc_module":4,"category_id":34,"category_name":35,"doc_title":65,"doc_description":67,"doc_content":134,"file_id":135,"file_url":136,"file_type":137,"file_size":138,"view_count":39,"is_deleted":4,"is_public":8,"is_downloadable":8,"audit_status":8,"page_count":139,"language":140,"language_code":63,"site_id":62,"html_lang":63,"table_of_contents":141,"faqs":142,"seo_title":143,"seo_description":67,"update_tm":144,"read_time":145,"preview_page_count":4},3985747859855,"https://ap-avatar.wpscdn.com/davatar_276721f389ce27ea32af1340a28f341c","Open access Review  \nRegulatory implications of ctDNA in immuno-oncology for solid tumors  \nPaz J Vellanki,1 Soma Ghosh,2 Anand Pathak,2 Michael J Fusco,1 Erik W Bloomquist,1 Shenghui Tang,1 Harpreet Singh,1,3 Reena Philip,3 Richard Pazdur,3 Julia A Beaver3  \nTo cite: Vellanki PJ, Ghosh S, Pathak A, et al. Regulatory implications of ctDNA in immuno-oncology for  \nsolid tumors. Journal for ImmunoTherapy of Cancer 2023;11:e005344 . doi:10 . 1136/ jitc-2022-005344  \nAccepted 14 October 2022  \nWatch Video  \n[jitc.bmj.com](jitc.bmj.com)  \n► [http://dx.doi.org/10.1136/](http://dx.doi.org/10.1136/)[ ](http://dx.doi.org/10.1136/)jitc-2022-006302  \n© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.  \n1Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA  \n2Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, Maryland, USA 3Oncology Center of Excellence, US Food and Drug Administration, Silver Spring, Maryland, USA  \nCorrespondence to  \nDr Paz J Vellanki;  \n[Paz.Vellanki@fda.hhs.gov](Paz.Vellanki@fda.hhs.gov)  \nABSTRACT  \nIn the era of precision oncology, use of circulating tumor DNA (ctDNA) is emerging as a minimally invasive approach for the diagnosis and management of patients with cancer and as an enrichment tool in clinical trials. In recent years, the US Food and Drug Administration has approved multiple ctDNA-based companion diagnostic assays for the safe and effective use of targeted therapies and ctDNA-based assays are also being developed for use with immuno-oncology-based therapies. For early-stage solid tumor cancers, ctDNA may be particularly important to detect molecular residual disease (MRD) to support early implementation of adjuvant or escalated therapy to prevent development of metastatic disease. Clinical trials are also increasingly using ctDNA MRD for patient selection and stratification, with an ultimate goal of improving trial efficiency through use of an enriched patient population. Standardization and harmonization of ctDNA assays and methodologies, along with further clinical validation of ctDNA as a prognostic and predictive biomarker, are necessary before ctDNA may be considered as an efficacyresponse biomarker to support regulatory decision making.  \nINTRODUCTION  \nCirculating tumor DNA (ctDNA) is an increasingly important biomarker being developed for the diagnosis and management of patients with cancer and is emerging as a regulatory tool to support efficient clinical trials and drug development. Measurement of ctDNA offers a minimally invasive approach to obtain valuable information about a tumor without having to rely on tissue biopsies.1 There are a number of clinical uses of ctDNA in development including for the diagnosis of cancer, to assess prognosis, and guide treatment decisions.2 3 In clinical trials, ctDNA may be used for patient selection based on detection of alterations for eligibility in a clinical trial, to identify high-risk and low- risk study populations, and to assess response to anticancer therapies.4 Although not currently validated for use, ctDNA also has potential asan early endpoint in clinical trials to support drug approvals.  \nTo date, several ctDNA-based companion diagnostic (CDx) assays have been approved  \nby the US Food and Drug Administration (FDA) as essential for the safe and effective use of a number of targeted therapies, primarily for the treatment of patients with metastatic cancers (table 1) .  \nThe earliest approvals were for PCR-based devices, such as Cobas EGFR Mutation Test V.2, for EGFR exon 19 deletions or exon 21 L858R mutations, for selection of patients with non-small cell lung cancer (NSCLC) for treatment with specific EGFR tyrosine kinase inhibitors. This was followed by approval of another PCR-based device, the therascreen PIK3CA RGQ PCR Kit, for identification of 11 PIK3CA mut","cbCairs4TGcpUnrB","https://ap.wps.com/l/cbCairs4TGcpUnrB","pdf",781091,11,"English","# Abstract\n# Introduction\n## ctDNA as a biomarker and regulatory tool\n## FDA-approved ctDNA-based companion diagnostics\n# Immune checkpoint inhibitors and clinical context","[{\"question\":\"What role does ctDNA play in precision oncology and clinical trials?\",\"answer\":\"ctDNA supports minimally invasive diagnosis and management, and it can enrich clinical trials by helping identify patients and stratify risk using molecular alterations and MRD signals.\"},{\"question\":\"How has the US FDA used ctDNA-based assays?\",\"answer\":\"The FDA has approved multiple ctDNA-based companion diagnostic assays for targeted therapies, primarily for selection of patients for specific treatments, and additional ctDNA assays are being developed for immuno-oncology.\"},{\"question\":\"Why are standardization and harmonization important for ctDNA regulatory acceptance?\",\"answer\":\"Standardization and harmonization of ctDNA assays and methodologies, along with further clinical validation, are needed so ctDNA can be accepted as a prognostic and predictive biomarker and ultimately an efficacy-response biomarker for regulatory decisions.\"}]","Regulatory implications of ctDNA in immuno-oncology for solid tumors | PDF",1790567071,28]