Loading
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a small trial suggested it added almost a year of life, but the large confirmatory trial found no benefit and it was withdrawn in 2019, a warning case for accelerated approvals.
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.
A human IgG1 antibody that binds platelet-derived growth factor receptor alpha and stops its ligands activating it on tumour and stromal cells.
1.Olaratumab binds its target.
Compare all products across the US, EU, UK, Japan, China and Australia →
In combination with doxorubicin for adults with soft tissue sarcoma with a histologic subtype for which an anthracycline-containing regimen is appropriate and which is not amenable to curative treatment with radiotherapy or surgery
Accelerated approval on a surrogate endpoint, with a confirmatory trial required.
In combination with doxorubicin for adults with soft tissue sarcoma with a histologic subtype for which an anthracycline-containing regimen is appropriate and which is not amenable to curative treatment with radiotherapy or surgery
Withdrawn: the indication came off the label 3.4 years after its accelerated approval.
| Region | Year | Indication |
|---|---|---|
| US | 2016 | Soft tissue sarcoma not curable by surgery or radiotherapy, with doxorubicin (accelerated approval) · Withdrawn in 2019 after the ANNOUNCE trial |
Country and place are remembered in this browser only. A postcode is sent to OpenStreetMap's Nominatim service to find coordinates when you press the button; nothing else leaves your device.
Query for this drug: (TITLE:"Olaratumab" OR ABSTRACT:"Olaratumab" OR TITLE:"Lartruvo" OR ABSTRACT:"Lartruvo" OR TITLE:"IMC-3G3" OR ABSTRACT:"IMC-3G3" OR TITLE:"LY3012207" OR ABSTRACT:"LY3012207") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Olaratumab, not a curated reading list.
Shares Eli Lilly (incl. Loxo) and the tag chembl-universe.
Shares Eli Lilly (incl. Loxo) and the tag chembl-universe.
Shares Doxorubicin and the tag chembl-universe.
Shares Doxorubicin and the tag chembl-universe.
Shares Doxorubicin and the tag chembl-universe.
Shares ANNOUNCE, Sarcomas (soft tissue, bone, GIST), Small-molecule kinase inhibitors.
Shares Small-molecule kinase inhibitors and the tag chembl-universe.
Shares Small-molecule kinase inhibitors and the tag chembl-universe.