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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

DateArticle
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

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