[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"doc-seo-383457-105":3,"detail-sidebar-cat-0-en-105":81,"doc-detail-383457-en":131},{"code":4,"msg":5,"data":6},0,"ok",{"site_id":7,"language":8,"slug":9,"title":10,"keywords":11,"description":12,"schema_data":13,"social_meta":74,"head_meta":76,"extra_data":78,"updated_unix":80},105,"en","kras-druggable-at-last","KRAS: Druggable at Last","","Accelerated FDA approval granted adagrasib for metastatic non-small cell lung cancer with KRAS G12C mutation after one prior therapy, positioning it alongside earlier sotorasib approval. The article frames KRAS as historically “undruggable,” then explains how covalent chemistry and recognition of a cryptic pocket enabled GDP-state locking to shut off oncogenic signaling. It compares efficacy and safety patterns across pivotal single-arm studies, highlighting broadly similar response rates but differences in toxicity and discontinuation, plus more available data for brain metastases.",{"@graph":14,"@context":73},[15,34,56],{"@type":16,"itemListElement":17},"BreadcrumbList",[18,23,27,31],{"item":19,"name":20,"@type":21,"position":22},"https://docshare.wps.com","Home","ListItem",1,{"item":24,"name":25,"@type":21,"position":26},"https://docshare.wps.com/document/","Document",2,{"item":28,"name":29,"@type":21,"position":30},"https://docshare.wps.com/document/healthcare/","Healthcare",3,{"item":32,"name":10,"@type":21,"position":33},"https://docshare.wps.com/document/kras-druggable-at-last/383457/",4,{"url":32,"name":10,"@type":35,"image":36,"author":41,"headline":10,"publisher":44,"fileFormat":47,"inLanguage":8,"description":12,"dateModified":48,"datePublished":49,"encodingFormat":47,"isAccessibleForFree":50,"interactionStatistic":51},"DigitalDocument",{"url":37,"@type":38,"width":39,"height":40},"https://docshare.wps.com/thumbnails/kras-druggable-at-last/383457.png","ImageObject",300,407,{"name":42,"@type":43},"Ivy","Person",{"url":19,"name":45,"@type":46},"DocShare","Organization","application/pdf","2026-11-01","2026-09-24",true,{"@type":52,"interactionType":53,"userInteractionCount":55},"InteractionCounter",{"@type":54},"ViewAction",11,{"@type":57,"mainEntity":58},"FAQPage",[59,65,69],{"name":60,"@type":61,"acceptedAnswer":62},"What is the FDA approval discussed in the article?","Question",{"text":63,"@type":64},"The article describes the FDA’s accelerated approval of adagrasib for metastatic non-small cell lung cancer with a KRAS G12C mutation after one prior therapy.","Answer",{"name":66,"@type":61,"acceptedAnswer":67},"Why was KRAS historically considered difficult to drug?",{"text":68,"@type":64},"KRAS is pharmacologically “untouchable” because its GTPase cycle is hard to disrupt directly, with no obvious allosteric sites and extremely strong binding requirements for the GTP/GDP system.",{"name":70,"@type":61,"acceptedAnswer":71},"How do adagrasib and sotorasib compare in the reported data?",{"text":72,"@type":64},"They are both allele-specific covalent inhibitors with broadly similar response rates and side-effect patterns, but the article notes adagrasib may have a slightly higher response rate while also showing a slightly higher rate of primary toxicity and discontinuation-related events.","https://schema.org",{"og:url":32,"og:type":75,"og:title":10,"og:site_name":45,"og:description":12},"article",{"robots":77,"canonical":32},"index,follow",{"doc_id":79,"site_id":7},383457,1790812262,{"code":4,"msg":82,"data":83},"success",[84,88,92,96,101,106,110,115,120,123,127],{"id":22,"doc_module":4,"doc_module_name":25,"category_name":85,"show_sort_weight":86,"slug":87},"Story & Novel",90,"story-novel",{"id":26,"doc_module":4,"doc_module_name":25,"category_name":89,"show_sort_weight":90,"slug":91},"Literature",80,"literature",{"id":33,"doc_module":4,"doc_module_name":25,"category_name":93,"show_sort_weight":94,"slug":95},"Exam",70,"exam",{"id":97,"doc_module":4,"doc_module_name":25,"category_name":98,"show_sort_weight":99,"slug":100},5,"Comic",60,"comic",{"id":102,"doc_module":4,"doc_module_name":25,"category_name":103,"show_sort_weight":104,"slug":105},6,"Technology",50,"technology",{"id":107,"doc_module":4,"doc_module_name":25,"category_name":29,"show_sort_weight":108,"slug":109},7,40,"healthcare",{"id":111,"doc_module":4,"doc_module_name":25,"category_name":112,"show_sort_weight":113,"slug":114},8,"Research & Report",30,"research-report",{"id":116,"doc_module":4,"doc_module_name":25,"category_name":117,"show_sort_weight":118,"slug":119},9,"Religion & Spirituality",20,"religion-spirituality",{"id":118,"doc_module":4,"doc_module_name":25,"category_name":121,"show_sort_weight":118,"slug":122},"World Cup","world-cup",{"id":124,"doc_module":4,"doc_module_name":25,"category_name":125,"show_sort_weight":124,"slug":126},10,"Lifestyle","lifestyle",{"id":128,"doc_module":4,"doc_module_name":25,"category_name":129,"show_sort_weight":97,"slug":130},19,"General","general",{"code":4,"msg":82,"data":132},{"doc_id":79,"user_id":133,"nickname":42,"user_avatar":134,"doc_module":4,"category_id":107,"category_name":29,"doc_title":10,"doc_description":12,"doc_content":135,"file_id":136,"file_url":137,"file_type":138,"file_size":139,"view_count":55,"is_deleted":4,"is_public":22,"is_downloadable":22,"audit_status":22,"page_count":33,"language":140,"language_code":8,"site_id":7,"html_lang":8,"table_of_contents":141,"faqs":142,"seo_title":143,"seo_description":12,"update_tm":144,"read_time":124},549758252649,"https://ap-avatar.wpscdn.com/avatar/8000253669c5317157?_k=1778319167496531819","KRAS: Druggable at Last  \nBenjamin O. Herzberg*,, GulamA. Manji  \nDepartment of Medicine, Division of Hematology/Oncology, Columbia University Irving Medical Center, New York, NY, USA  \n*Corresponding author: Benjamin O. Herzberg, MD, Columbia University Irving Medical Center, New York, NY, USA. Email: [boh2109@cumc.columbia.edu](boh2109@cumc.columbia.edu)  \nIn early December, the US Food and Drug Administration granted accelerated approval to adagrasib, a mutant-selective inhibitor of the Kirsten rat sarcoma viral homolog (KRAS), for the treatment of metastatic non-small cell lung cancer (NSCLC) harboring a KRAS G12C mutation after one prior therapy.1 Adagrasib now joins sotorasib,2 which received accelerated approval in May, 2021 for the same indication. In some ways, the arrival of adagrasib simply represents a continuation of what we learned a year prior: that KRAS was, at long last, an oncogene that we could shift from the “undruggable”column to the “druggable” one.3 But this approval underlies something else: a confluence of new biology, new chemistry, new clinical questions, and new avenues of drug discovery. From this vantage point, the approval of adagrasib looks not so much like the beginning of the end for KRASmutated cancers, but something much closer to the end of the beginning.  \nKRAS was among the first discovered human oncogenes. It was a member of the initial group of so-called viral oncogenes whose existence was traced not to the retroviruses in which they were initially identified but instead to the endogenous genome of the cell—proving that the keys to cancer were not outside, but within, the human genome.4 Overtime, KRAS grew in importance, chiefly for 2 features: it is among the most mutated of all oncogenes across all histologies and its biology and biochemistry made it pharmacologically untouchable.5 The KRAS protein is a GTPase that integrates activity from upstream receptor tyrosine kinases (RTKs) and signals downstream to regulate cell growth. To do this, it cycles between a protein “on” state, or KRAS(on), in which it is bound to GTP, and a KRAS(off) state, in which it is GDP-bound. KRAS contains an internal system to shut itself off, by activating its GTPase function; a variety of helper proteins regulate KRAS activity by shifting the balance between KRAS(GDP) and KRAS(GTP) . Oncogenic mutations in KRAS shift the balance toward perpetual activity—and unchecked growth. It is an elegant system but so elegant that almost no exogenous molecule could directly disrupt it. In the 2000s, an era where oncogenic kinase after kinase fell to drug hunters and medicinal chemists, KRAS played on, unperturbed. It has a picomolar affinity for GTP (which is micromolar abundant in cells), an interaction nothing could displace. It had no obvious allosteric sites. It was uncrackable safe.  \nThe insight that would eventually become sotorasib and adagrasib took advantage of the rise—or rerise—of covalent molecules as human drugs.6 The (re)discovery of the uses of covalency has allowed for overcoming resistance and developing more selective cancer drugs in other settings, such as Bruton’s tyrosine kinase (BTK) inhibitors or the 3rd-generation epidermal growth factor receptor (EGFR) TKI, osimertinib. But in the case of targeting KRAS, it was covalency itself that was the starting point. The insight was first reported by Ostremand Shokat,7 who noted that one particular KRAS mutation, the p.G12C mutation, replaced an inert glycine with a reactive cysteine. They screened small cysteine-reactive molecular fragments against it. Building up from these fragments, they discovered a cryptic pocket adjacent to the GDP binding site. They synthesized a molecule that could bind the KRAS(GDP), locking it in that state, such that it was unable to cycle to GTP-bound KRAS(on) . GTP-GDP shuttling, in the presence of an inhibitor, turns the system off.8 With this foothold, more selective molecules followed. From tool compound to efficacy in ","cbCaigwaWlBUEweP","https://ap.wps.com/l/cbCaigwaWlBUEweP","pdf",166656,"English","# FDA accelerated approval and clinical context\n## From “undruggable” to “druggable”\n# KRAS biology and the challenge of direct disruption\n## GTPase on/off cycling\n# Covalent targeting strategy\n## GDP-state locking and key discoveries\n# Comparing adagrasib vs sotorasib\n## Response, toxicity, and CNS activity","[{\"question\":\"What is the FDA approval discussed in the article?\",\"answer\":\"The article describes the FDA’s accelerated approval of adagrasib for metastatic non-small cell lung cancer with a KRAS G12C mutation after one prior therapy.\"},{\"question\":\"Why was KRAS historically considered difficult to drug?\",\"answer\":\"KRAS is pharmacologically “untouchable” because its GTPase cycle is hard to disrupt directly, with no obvious allosteric sites and extremely strong binding requirements for the GTP/GDP system.\"},{\"question\":\"How do adagrasib and sotorasib compare in the reported data?\",\"answer\":\"They are both allele-specific covalent inhibitors with broadly similar response rates and side-effect patterns, but the article notes adagrasib may have a slightly higher response rate while also showing a slightly higher rate of primary toxicity and discontinuation-related events.\"}]","KRAS: Druggable at Last | PDF",1790257140]