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FDA Approves Olaratumab for Soft Tissue Sarcoma

Dr. Richard Pazdur from the FDA's Center for Drug Evaluation and Research

Richard Pazdur, MD

The FDA has granted an accelerated approval to the PDGFRα antagonist olaratumab (Lartruvo) in combination with doxorubicin for the treatment of patients with advanced soft tissue sarcoma (STS) who are not candidates for radiotherapy or surgery.

The approval was based on data from the phase II JGDG trial, in which combining olaratumab with doxorubicin reduced the risk of death by 54% versus doxorubicin alone in patients with STS (HR, 0.46; 95% CI, 0.30-0.71; P = .0003). The median overall survival (OS) in the intent-to-treat population (n = 129) was improved by 11.8 months with the olaratumab combination versus doxorubicin alone.

"For these patients, Lartruvo, added to doxorubicin, provides a new treatment option," Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research and acting director of the FDA’s Oncology Center of Excellence, said in a statement. "This is the first new therapy approved by the FDA for the initial treatment of soft tissue sarcoma since doxorubicin’s approval more than 40 years ago." Click here to read the full article at

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