The FDA has granted Priority Review for the biologics license application (BLA) for olaratumab, a PDGFRα antagonist, 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.
Eli Lilly has received additional designations for olaratumab from the FDA, including Breakthrough Therapy, Fast Track and Orphan Drug, for this indication. According to the FDA, Breakthrough Therapy designation is a process designed to expedite the development of a potential medicine that is intended to treat a serious condition, and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint.
Providing Priority Review status for olaratumab reinforces that olaratumab is a potential medicine that treats a serious condition and can provide significant improvement in the treatment of people with advanced STS. Submission was completed in the first quarter of 2016.
The BLA submission for olaratumab was based upon the results from a pivotal Phase II 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.
Eli Lilly also submitted olaratumab to the European Medicines Agency (EMA) in the first quarter of 2016, and the application is currently being reviewed under an accelerated assessment schedule.