Skip to Content

Lartruvo Approval History

Lartruvo (olaratumab) is a platelet-derived growth factor receptor alpha (PDGFR-α) blocking antibody indicated in combination with doxorubicin for the treatment of patients with advanced soft tissue sarcoma (STS).

Lartruvo was granted accelerated approval for adults with a histologic subtype of STS for which an anthracycline-containing regimen is appropriate, and which cannot be cured with radiotherapy or surgery. Approval was based on safety and efficacy data from the Phase 2 JGDG trial of 133 patients. Patients treated with Lartruvo and doxorubicin had a statistically significant improvement in median overall survival, with median survival of 26.5 months compared to 14.7 months for patients who received doxorubicin alone.

Lartruvo is administered via intravenous infusion. Serious risks include infusion-related reactions and embryo-fetal harm. Common side effects include nausea, fatigue, neutropenia, musculoskeletal pain, mucositis, alopecia, vomiting, diarrhea, decreased appetite, abdominal pain, neuropathy and headache.

Development History and FDA Approval Process for Lartruvo

Oct 19, 2016Approval FDA Grants Accelerated Approval to Lartruvo (olaratumab) for Advanced Soft Tissue Sarcoma
May  4, 2016FDA Grants Priority Review For Lilly's Olaratumab, An Investigational Medicine For Advanced Soft Tissue Sarcoma

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.