The company’s biologics license application included results from a pivotal phase 2 open-label, randomized trial that assessed the addition of olaratumab to doxorubicin chemotherapy in patients with advanced soft tissue sarcoma who are not responsive to curative treatment with surgery or radiotherapy.
A phase 3 study of olaratumab and doxorubicin in advanced soft tissue sarcoma is presently enrolling adult patients.
Lilly Oncology senior vice president of product development and medical affairs Richard Gaynor said: "We are encouraged that the FDA has granted Priority Review for olaratumab as a potential treatment for advanced soft tissue sarcoma.
"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."
The FDA has already granted breakthrough therapy designation, fast track status and orphan drug designation for olaratumab.
The application is currently being reviewed by the European Medicines Agency under an accelerated assessment schedule.
Olaratumab is a human IgG1 monoclonal antibody designed to bind to human platelet-derived growth factor (PDGF) receptor a with high affinity and block PDGF-AA, PDGF-BB, and PDGF-CC ligands from binding to the receptor.
It could result in anticancer activity by targeting tumor cells directly, as well as cells that surround and support tumor growth.
Image: Lilly corporate headquarters (Indianapolis, Indiana). Photo: courtesy of Eli Lilly and Company.