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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.

Citation:

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.