FDA Grants Priority Review for BLA for Olaratumab in Advanced Soft-Tissue Sarcoma

Eli Lilly and Company announced today that the U.S. Food and Drug Administration (FDA) has granted Priority Review for the biologics license application (BLA) for olaratumab, a platelet-derived growth factor receptor alpha (PDGFRα) antagonist, in combination with doxorubicin, for the potential treatment of patients with advanced soft-tissue sarcoma not amenable to curative treatment with radiotherapy or surgery.

Olaratumab is a human IgG1 monoclonal antibody that is designed to disrupt the PDGFRα pathway on tumor cells and on cells in the tumor microenvironment. Lilly has received additional designations for olaratumab from the FDA, including Breakthrough Therapy, Fast Track, and Orphan Drug, for this indication.

“We are encouraged that the FDA has granted Priority Review for olaratumab as a potential treatment for advanced soft-tissue sarcoma,” said Richard Gaynor, MD, Senior Vice President, Product Development and Medical Affairs for Lilly Oncology. “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 BLA submission for olaratumab was based on the results of 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 soft-tissue sarcoma not amenable to curative treatment with surgery or radiotherapy. Results from JGDG were presented at the 2015 ASCO Annual Meeting (Abstract 10501) and the 2015 Connective Tissue Oncology Society Annual Meeting.

Lilly also submitted olaratumab to the European Medicines Agency in the first quarter of 2016, and that application is currently being reviewed under an accelerated assessment schedule. 

A phase III trial of olaratumab and doxorubicin in advanced soft-tissue sarcoma is currently recruiting adult patients (clinicaltrials.gov identifier: NCT02451943).

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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