# OnCo record paper-drug-dosing-conundrum-nejm-2021 (paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)". Whole corpus: https://onco.cc/api/v1/onco.nt
@prefix schema: <https://schema.org/> .
@prefix onco: <https://onco.cc/ns#> .
@prefix xsd: <http://www.w3.org/2001/XMLSchema#> .

<https://onco.cc/key-papers/paper-drug-dosing-conundrum-nejm-2021/>
  a schema:ScholarlyArticle ;
  onco:kind "paper" ;
  schema:identifier "paper-drug-dosing-conundrum-nejm-2021" ;
  schema:name "FDA's Project Optimus manifesto: cancer drugs are approved at doses that are too high"@en ;
  schema:description "FDA oncology leaders argued that the maximum tolerated dose paradigm inherited from chemotherapy produces targeted drugs and immunotherapies dosed far above what is needed, using sotorasib (960 mg vs 240 mg) as the case study, and launched Project Optimus to require dose optimisation before approval."@en ;
  schema:url <https://onco.cc/key-papers/paper-drug-dosing-conundrum-nejm-2021/> ;
  schema:dateModified "2026-09-08"^^xsd:date ;
  schema:citation <https://doi.org/10.1056/NEJMp2109826>, <https://www.fda.gov/about-fda/oncology-center-excellence/project-optimus> ;
  schema:sameAs <https://doi.org/10.1056/NEJMp2109826> ;
  schema:datePublished "2021"^^xsd:gYear ;
  schema:author "Shah M, Rahman A, Theoret MR, Pazdur R" ;
  onco:related <https://onco.cc/ideas/idea-tr1-randomised-dose-comparison-before-pivotal/>, <https://onco.cc/ideas/idea-tr1-exposure-response-before-dose-selection/>, <https://onco.cc/ideas/idea-moon-post-approval-dose-deescalation/>, <https://onco.cc/ideas/idea-reg-global-dose-optimisation-guideline/> ;
  onco:sections <https://onco.cc/fronts/targeted-therapy/> ;
  onco:technologies <https://onco.cc/technologies/kinase-inhibitors/> ;
  onco:targets <https://onco.cc/targets/kras/> ;
  onco:drugs <https://onco.cc/drugs/sotorasib/>, <https://onco.cc/drugs/niraparib/> ;
  onco:terms <https://onco.cc/terms/project-optimus/>, <https://onco.cc/terms/accelerated-approval/> ;
  onco:bottlenecks <https://onco.cc/bottlenecks/b-dose-optimisation/>, <https://onco.cc/bottlenecks/b-toxicity-qol/>, <https://onco.cc/bottlenecks/b-regulatory-fragmentation/> ;
  onco:journals <https://onco.cc/journals/nejm/> .