{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,1]],"date-time":"2026-10-01T05:58:39Z","timestamp":1790834319943,"version":"4.1.0"},"reference-count":12,"publisher":"Elsevier BV","issue":"9","license":[{"start":{"date-parts":[[2020,9,1]],"date-time":"2020-09-01T00:00:00Z","timestamp":1598918400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"},{"start":{"date-parts":[[2020,9,1]],"date-time":"2020-09-01T00:00:00Z","timestamp":1598918400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/legal\/tdmrep-license"},{"start":{"date-parts":[[2021,9,1]],"date-time":"2021-09-01T00:00:00Z","timestamp":1630454400000},"content-version":"vor","delay-in-days":365,"URL":"http:\/\/www.elsevier.com\/open-access\/userlicense\/1.0\/"}],"funder":[{"DOI":"10.13039\/100007723","name":"Takeda Pharmaceuticals U.S.A.","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100007723","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100014848","name":"Arnold Ventures","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100014848","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100004319","name":"Pfizer","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004319","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100004337","name":"Roche","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004337","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["annalsofoncology.org","elsevier.com","sciencedirect.com"],"crossmark-restriction":true},"short-container-title":["Annals of Oncology"],"published-print":{"date-parts":[[2020,9]]},"DOI":"10.1016\/j.annonc.2020.07.001","type":"journal-article","created":{"date-parts":[[2020,8,5]],"date-time":"2020-08-05T08:03:01Z","timestamp":1596614581000},"page":"1112-1114","update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":95,"title":["The FDA approval of pembrolizumab for patients with TMB >10 mut\/Mb: was it a wise decision? No"],"prefix":"10.1016","volume":"31","author":[{"given":"V.","family":"Prasad","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"A.","family":"Addeo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"78","reference":[{"issue":"7","key":"10.1016\/j.annonc.2020.07.001_bib2","doi-asserted-by":"crossref","first-page":"934","DOI":"10.1001\/jamaoncol.2019.0626","article-title":"Tumor mutation burden\u2014from hopes to doubts","volume":"5","author":"Addeo","year":"2019","journal-title":"JAMA Oncol"},{"issue":"21","key":"10.1016\/j.annonc.2020.07.001_bib3","doi-asserted-by":"crossref","first-page":"2020","DOI":"10.1056\/NEJMoa1910231","article-title":"Nivolumab plus ipilimumab in advanced non-small-cell lung cancer","volume":"381","author":"Hellmann","year":"2019","journal-title":"N\u00a0Engl J Med"},{"issue":"5","key":"10.1016\/j.annonc.2020.07.001_bib4","doi-asserted-by":"crossref","first-page":"300","DOI":"10.1038\/s41571-019-0316-z","article-title":"Immunotherapeutic approaches for small-cell lung cancer","volume":"17","author":"Iams","year":"2020","journal-title":"Nat Rev Clin Oncol"},{"key":"10.1016\/j.annonc.2020.07.001_bib5","doi-asserted-by":"crossref","first-page":"196","DOI":"10.1016\/j.ejca.2018.11.012","article-title":"A\u00a0systematic review of trial-level meta-analyses measuring the strength of association between surrogate end-points and overall survival in oncology","volume":"106","author":"Haslam","year":"2019","journal-title":"Eur J Cancer"},{"issue":"11","key":"10.1016\/j.annonc.2020.07.001_bib6","doi-asserted-by":"crossref","first-page":"656","DOI":"10.1038\/s41571-019-0260-y","article-title":"A\u00a0reality check of the accelerated approval of immune-checkpoint inhibitors","volume":"16","author":"Gill","year":"2019","journal-title":"Nat Rev Clin Oncol"},{"issue":"3","key":"10.1016\/j.annonc.2020.07.001_bib7","doi-asserted-by":"crossref","first-page":"e509","DOI":"10.1016\/j.amjmed.2018.08.017","article-title":"The tradeoff of cancer drug regulatory policy: faster approvals for one means less knowledge for another","volume":"132","author":"Tao","year":"2019","journal-title":"Am J Med"},{"issue":"11","key":"10.1016\/j.annonc.2020.07.001_bib9","doi-asserted-by":"crossref","first-page":"2598","DOI":"10.1158\/1535-7163.MCT-17-0386","article-title":"Tumor mutational burden as an independent predictor of response to immunotherapy in diverse cancers","volume":"16","author":"Goodman","year":"2017","journal-title":"Mol Cancer Ther"},{"issue":"7","key":"10.1016\/j.annonc.2020.07.001_bib12","doi-asserted-by":"crossref","first-page":"883","DOI":"10.1016\/S1470-2045(16)30098-5","article-title":"Nivolumab alone and nivolumab plus ipilimumab in recurrent small-cell lung cancer (CheckMate 032): a multicentre, open-label, phase 1\/2 trial","volume":"17","author":"Antonia","year":"2016","journal-title":"Lancet Oncol"},{"issue":"3","key":"10.1016\/j.annonc.2020.07.001_bib14","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1200\/PO.18.00283","article-title":"Prospective comprehensive genomic profiling of primary and metastatic prostate tumors","author":"Chung","year":"2019","journal-title":"JCO Precis Oncol"},{"issue":"2","key":"10.1016\/j.annonc.2020.07.001_bib15","doi-asserted-by":"crossref","first-page":"157","DOI":"10.1001\/jamaoncol.2017.4182","article-title":"Cancer drugs approved based on biomarkers and not tumor type\u2014FDA approval of pembrolizumab for\u00a0mismatch repair-deficient solid cancers","volume":"4","author":"Prasad","year":"2018","journal-title":"JAMA Oncol"},{"issue":"5","key":"10.1016\/j.annonc.2020.07.001_bib16","doi-asserted-by":"crossref","first-page":"642","DOI":"10.1001\/jamainternmed.2018.8351","article-title":"Estimation of study time reduction using surrogate end points rather than overall survival in oncology clinical trials","volume":"179","author":"Chen","year":"2019","journal-title":"JAMA Intern Med"},{"issue":"6","key":"10.1016\/j.annonc.2020.07.001_bib18","doi-asserted-by":"crossref","first-page":"381","DOI":"10.1038\/nrclinonc.2017.31","article-title":"The high price of anticancer drugs: origins, implications, barriers, solutions","volume":"14","author":"Prasad","year":"2017","journal-title":"Nat Rev Clin Oncol"}],"container-title":["Annals of Oncology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S092375342039935X?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S092375342039935X?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"}],"deposited":{"date-parts":[[2025,10,13]],"date-time":"2025-10-13T05:57:02Z","timestamp":1760335022000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S092375342039935X"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,9]]},"references-count":12,"journal-issue":{"issue":"9","published-print":{"date-parts":[[2020,9]]}},"alternative-id":["S092375342039935X"],"URL":"https:\/\/doi.org\/10.1016\/j.annonc.2020.07.001","relation":{},"ISSN":["0923-7534"],"issn-type":[{"value":"0923-7534","type":"print"}],"subject":[],"published":{"date-parts":[[2020,9]]},"assertion":[{"value":"Elsevier","name":"publisher","label":"This article is maintained by"},{"value":"The FDA approval of pembrolizumab for patients with TMB >10 mut\/Mb: was it a wise decision? No","name":"articletitle","label":"Article Title"},{"value":"Annals of Oncology","name":"journaltitle","label":"Journal Title"},{"value":"https:\/\/doi.org\/10.1016\/j.annonc.2020.07.001","name":"articlelink","label":"CrossRef DOI link to publisher maintained version"},{"value":"https:\/\/doi.org\/10.1016\/j.annonc.2020.07.002","name":"associatedlink","label":"CrossRef DOI link to the associated document"},{"value":"simple-article","name":"content_type","label":"Content Type"},{"value":"\u00a9 2020 European Society for Medical Oncology. Published by Elsevier Ltd.","name":"copyright","label":"Copyright"}]}}