{"entity":{"id":"olaratumab","kind":"drug","name":"Olaratumab","aka":["IMC-3G3","LY3012207"],"tldr":"Olaratumab was approved in 2016 with doxorubicin for soft tissue sarcoma after a small trial suggested it added almost a year of life, but the large confirmatory trial found no benefit and it was withdrawn in 2019, a warning case for accelerated approvals.","summary":"Eli Lilly's olaratumab received FDA accelerated approval in October 2016, and EU conditional approval the same year, for adults with soft tissue sarcoma not curable by surgery or radiotherapy, in combination with doxorubicin, after a randomised phase 2 trial reported median survival of 26.5 months versus 14.7 months with doxorubicin alone. The phase 3 ANNOUNCE trial in 509 patients then showed no difference in overall survival, and Lilly withdrew the drug worldwide in 2019. The episode is cited whenever the reliability of small randomised phase 2 survival signals is debated.","status":"withdrawn","asOf":"2026-09-08","wikipedia":"https://en.wikipedia.org/wiki/Olaratumab","links":[{"label":"Wikipedia","url":"https://en.wikipedia.org/wiki/Olaratumab"},{"label":"ChEMBL CHEMBL2109625","url":"https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2109625"}],"tags":["gap-fill","chembl-universe"],"related":[],"cancers":["sarcoma"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["doxorubicin"],"companies":["eli-lilly"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"notes":[],"brand":"Lartruvo","modality":"Anti-PDGFR alpha monoclonal antibody, intravenous","mechanism":"A human IgG1 antibody that binds platelet-derived growth factor receptor alpha and stops its ligands activating it on tumour and stromal cells.","approvals":[{"region":"US","year":2016,"indication":"Soft tissue sarcoma not curable by surgery or radiotherapy, with doxorubicin (accelerated approval)","note":"Withdrawn in 2019 after the ANNOUNCE trial"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/olaratumab/","neighbours":{"cancer":[{"id":"sarcoma","kind":"cancer","name":"Sarcomas (soft tissue, bone, GIST)","route":"/cancers/sarcoma/"}],"technology":[{"id":"kinase-inhibitors","kind":"technology","name":"Small-molecule kinase inhibitors","route":"/technologies/kinase-inhibitors/"}],"drug":[{"id":"doxorubicin","kind":"drug","name":"Doxorubicin","route":"/drugs/doxorubicin/"}],"company":[{"id":"eli-lilly","kind":"company","name":"Eli Lilly (incl. Loxo)","route":"/companies/eli-lilly/"}]}}