The U.S. Food and Drug Administration (FDA) recently approved of a priority review of the biologics license application (BLA) for olaratumab, a medicine designed to treat advanced soft tissue sarcoma (STS).
Olaratumab, developed by Eli Lilly and Company, is a PDGFR antagonist that is to be combined with doxorubicin. It is not amenable for curing treatments with surgeries or radiotherapies.
The FDA has given further designations for Lilly’s new olaratumab treatments. These include Fast Track, Breakthrough Therapy and Orphan Drug. The goal is to accelerate the development of this medicine, as it could treat a major, serious health condition.
As of today, preliminary clinical evidence suggests that olaratumab could be more effective than current therapies used to treat advanced STS.
"We are encouraged that the FDA has granted priority review for olaratumab as a potential treatment for advanced soft tissue sarcoma," Richard Gaynor, senior vice president of product development and medical affairs for Lilly Oncology, said. "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 advances granted to Lilly are established on positive results from the company’s mile marker phase-two trial called JGDG. This open-label, randomized study compared patients’ results when they combined doxorubicin chemotherapy with doxorubicin by itself.
