Lartruvo Gets Accelerated Approval by FDA for Sarcoma treatment

October 2016

The Food and Drug Administration (FDA) granted accelerated approval to the drug Lartruvo (olaratumab) in combination with doxorubicin for patients with soft tissue sarcomas. Produced by Eli Lilly & Company, Lartruvo targets platelet-derived growth factor receptor-alpha (PDGFRα), which is expressed in some sarcomas.  The accelerated approval is based on data from the Phase II portion of the JGDG trial. This was an open label randomized phase II study where 133 patients received doxorubicin with or without olaratumab. The risk of death was reduced by nearly half (48%) in the combination doxorubicin/olaratumab arm as compared to doxorubicin alone (HR = 0.52, 95% CI 0.34-0.79, p<0.05). Median overall survival was 26.5 months versus 14.7 months in the doxorubicin/olaratumab and doxorubicin arms, respectively.  The median progression-free survival (PFS) was 8.2 months in the doxorubicin/olaratumab arm versus 4.1 months in the doxorubicin single agent arm (HR = 0.67; 95% CI 0.40-1.12; p = 0.12). The combination arm patients received more cycles of doxorubicin and in general reported more frequent adverse events including GI symptoms, fatigue, and low blood counts.  Continued approval for olaratumab will be contingent upon verification and demonstration of clinical benefit to patients in the confirmatory Phase 3 clinical trial, ANNOUNCE, which is already fully enrolled.