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FDA Approves Lartruvo for Soft Tissue Sarcoma
Eli Lilly news release; 2016 Oct 19
The FDA has approved Lartruvo (olaratumab), in combination with doxorubicin, for the treatment of adults with soft tissue sarcoma (STS).
Indications: Lartruvo is a platelet-derived growth factor receptor alpha blocking antibody indicated, in combination with doxorubicin, for the treatment of adult patients with STS with a histologic subtype for which an anthracycline-containing regimen is appropriate and which is not amenable to curative treatment with radiotherapy or surgery.
Dosage and administration: Administer at 15 mg/kg as an IV infusion over 60 minutes on Days 1 and 8 of each 21-day cycle until disease progression or unacceptable toxicity. Administer with doxorubicin during first 8 cycles.
Efficacy and safety: Approval is based on a trial that showed that Lartruvo, in combination with doxorubicin chemotherapy, improved overall survival by 11.8 months, vs doxorubicin alone.
Side effects/risks: Most common adverse reactions are nausea, fatigue, musculoskeletal pain, mucositis, alopecia, vomiting, diarrhea, decreased appetite, abdominal pain, neuropathy, and headache.
FDA approves Lilly's Lartruvo (olaratumab) in combination with doxorubicin for soft tissue sarcoma [news release]. Indianapolis, IN: Eli Lilly and Company October 19, 2016. http://www.prnewswire.com/news-releases/fda-approves-lillys-lartruvo-olaratumab-in-combination-with-doxorubicin-for-soft-tissue-sarcoma-300347858.html. Accessed October 26, 2016.
Lartruvo [package insert]. Indianapolis, IN: Eli Lilly and Company 2016. http://pi.lilly.com/us/lartruvo-uspi.pdf. Accessed October 26, 2016.