The Food and Drug Administration has granted priority review of olaratumab, in combination with doxorubicin, for the treatment of patients with advanced soft tissue sarcoma who unsuccessfully underwent prior radiotherapy or surgery for their cancer.
Olaratumab is a human IgG1 monoclonal antibody that directly targets tumor cells by disrupting the platelet-derived growth factor receptor alpha, a receptor that is believed to play a role in tumor growth and progression.
“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,” Dr. Richard Gaynor, senior vice president of product development and medical affairs for Lilly Oncology, the maker of the drug, said in a written statement issued by company.
The biologics license application submission for olaratumab was based on a phase II clinical trial of 129 patients with metastatic or unresectable soft tissue sarcoma. Sixty-four patients were assigned to the treatment group and received both doxorubicin and olaratumab. Patients in this group continued to receive olaratumab through observed disease progression. Sixty-five patients were assigned to the control group and received only doxorubicin until disease progression was first observed. Patients who received olaratumab in addition to doxorubicin experienced a longer median progression-free survival, compared with patients who only received doxorubicin (6.6 months vs. 4.1 months; stratified hazard ratio, 0.672; 95% confidence interval, 0.442 to 1.021; P = .0615). The results of the phase II clinical trial were reported at the 2015 American Society of Clinical Oncology annual meeting and the 2015 Connective Tissue Oncology Society annual meeting.
The FDA previously granted olaratumab breakthrough therapy, fast track, and orphan drug designation.
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