Eli Lilly and Company announced that the US Food and Drug Administration (FDA) has granted Priority Review for the biologics license application (BLA) for olaratumab. Olaratumab is a human IgG1 monoclonal antibody that is designed to disrupt the PDGF Receptor-a (platelet-derived growth factor receptor a) pathway on tumor cells. In combination with doxorubicin it is used 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. The BLA submission for olaratumab was based upon the results from 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 were presented at the 2015 American Society of Clinical Oncology annual meeting and the 2015 Connective Tissue Oncology Society annual meeting. Submission was completed in the first quarter of 2016. Lilly also submitted olaratumab to the European Medicines Agency (EMA) in the first quarter of 2016.
"We are encouraged that the FDA has granted Priority Review for olaratumab as a potential treatment for advanced soft tissue sarcoma," said Richard Gaynor, M.D., senior vice president, product development and medical affairs for Lilly Oncology.
