FDA Approves Lartruvo in Combination with Doxorubicin for Soft Tissue Sarcoma
It was announced that the U.S. Food and Drug Administration (FDA) has granted approval of Lartruvo™ (olaratumab), in combination with doxorubicin, for the treatment of adults with soft tissue sarcoma (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. Lartruvo, in combination with doxorubicin, is the first FDA-approved front-line therapy for STS in four decades.
Sarcomas are a diverse and relatively rare type of cancer that usually develop in the connective tissue of the body, which include fat, blood vessels, nerves, bones, muscles, deep skin tissues, and cartilage. Soft tissue sarcoma is a complex disease with multiple subtypes, making it very hard to diagnose and difficult to treat. For decades, there have been no front-line therapeutic advancements for STS that have improved overall survival. According to the American Cancer Society, in 2015, there were an estimated 12,000 new STS cases diagnosed and nearly 5,000 deaths in the U.S. alone.
Lartruvo is a platelet-derived growth factor receptor alpha (PDGFR-?) blocking antibody that specifically binds PDGFR-? and prevents receptor activation inhibiting sarcoma growth. Lartruvo is the first monoclonal antibody approved to treat STS.
The approval of Lartruvo is based on the results of a clinical study of 133 patients, which compared Lartruvo, in combination with doxorubicin chemotherapy, to doxorubicin alone in patients with STS with a histologic subtype for which an anthracycline-containing regimen was appropriate and which is not amenable to curative treatment with surgery or radiotherapy.
Median overall survival was improved by 11.8 months in patients treated with Lartruvo plus doxorubicin compared to patients treated with doxorubicin alone. Lartruvo was well tolerated and represents the first significant advance in the management of sarcomas in years.
Reference: FDA. (2016.) FDA grants accelerated approval to new treatment for advanced soft tissue sarcoma. [Press release.] Retrieved from http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm525878.htm
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