Eli Lilly and Company announced today that the U.S. FDA has granted Priority Review for the biologics license application (BLA) for olaratumab, a PDGFRα antagonist, in combination with doxorubicin, for the potential treatment of people with advanced soft tissue sarcoma (STS) not amenable to curative treatment with radiotherapy or surgery. Lilly has received additional designations for olaratumab from the FDA, including Breakthrough Therapy, Fast Track and Orphan Drug, for this indication.
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 (STS) is a complex disease with multiple subtypes, making it very difficult to treat. According to the American Cancer Society, in 2015 an estimated 12,000 new cases of STS were diagnosed, and nearly 5,000 deaths from STS occurred in the U.S. alone.