FDA Grants Priority Review to Olaratumab for Advanced Soft Tissue Sarcoma

Lilly’s investigational drug previously received other FDA designations

The FDA has granted priority review to the biologics license application (BLA) for olaratumab (Eli Lilly and Company) 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.

Olaratumab, a platelet-derived growth factor receptor-alpha (PDGFRα) antagonist, previously received FDA breakthrough therapy, fast track, and orphan drug designations for this indication. "We are hopeful that, if approved, olaratumab will provide a meaningful addition to the limited treatment options for this rare and difficult-to-treat disease," said Richard Gaynor, MD, senior vice president for product development and medical affairs at Lilly Oncology.

The BLA submission for olaratumab was based on the results of a pivotal phase 2 trial, JGDG, an open-label, randomized study that compared olaratumab in combination with doxorubicin chemotherapy to doxorubicin alone in patients with advanced STS not amenable to curative treatment with surgery or radiotherapy.

Results from JGDG involving the treatment of 129 patients were presented at the 2015 American Society of Clinical Oncology annual meeting. Among patients receiving olaratumab and doxorubicin compared with those receiving doxorubicin alone, median progression-free survival was 6.6 months versus 4.1 months; median overall survival in an interim analysis was 25.0 months versus 14.7 months; and objective response rates were 18.8% versus 12.3%.

Lilly also submitted olaratumab to the European Medicines Agency in the first quarter of 2016, and the application is being reviewed under an accelerated assessment schedule.

Olaratumab is a human IgG1 monoclonal antibody that is designed to disrupt the PDGFRα pathway on tumor cells and on cells in the tumor microenvironment. This means it may cause anticancer activity by targeting tumor cells directly, as well as cells that surround and support tumor growth. A phase 3 trial of olaratumab and doxorubicin in advanced STS is recruiting adult patients.

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.

Sources: Eli Lilly and Company; May 4, 2016; and ASCO; 2015.