Abstract
In the European Union, Lartruvo(R) (olaratumab) has been conditionally registered and approved under the Phase 2 study in the European Union on 9 November 2016 with the status of Orphan Drug - rare disease medication for the treatment of patients with advanced soft-tissue sarcoma. Olaratumab is a human monoclonal antibody binding to the PDGFR (platelet derived growth factor receptor) alpha and blocking ligand binding and activation of the receptor signal pathway.
It represents the first biological treatment that clinically significantly prolonged overall survival when combined with doxorubicin, compared to the standard of doxorubicin monotherapy and achieved a median survival of 80%, i.e. 11.8 months from 14.7 to 26.5 months, and reducing the risk of death by 54% (hazard ratio 0.463; p = 0.0003).