Lilly’s Olaratumab Gets Priority Review for Soft Tissue Sarcoma

FDA has granted priority review to Eli Lilly for a BLA for olaratumab to be used in combination with doxorubicin, for the potential treatment of advanced soft tissue sarcoma (STS) not amenable to curative treatment with radiotherapy or surgery. Olaratumab is a human IgG1 monoclonal antibody, according to the company, that is designed to disrupt the PDGF Receptor-a (platelet-derived growth factor receptor a) pathway on tumor cells and on cells in the tumor microenvironment. The BLA submission was based upon the results from a Phase 2 trial 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, Lilly says.

It has also received breakthrough therapy, fast-track and orphan drug designations from FDA for this indication.