FDA Grants Priority Review to Olaratumab for Advanced Soft Tissue Sarcoma

The U.S. Food and Drug Administration (FDA) has granted Priority Review for the biologics license application for olaratumab, in combination with doxorubicin, for the potential treatment of patients with advanced soft tissue sarcoma who are not amenable to curative treatment with surgery or radiotherapy.¹

“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 biologics license application for olaratumab was based upon findings from an open-label, randomized, phase 2 trial that compared the efficacy and safety of olaratumab plus doxorubicin with that of doxorubicin alone in patients with advanced soft tissue sarcoma.

Olaratumab, which has previously received Breakthrough Therapy Designation by the FDA, is a human IgG1 monoclonal antibody that disrupts the platelet-derived growth factor receptor α (PDGFR- α) pathway on tumor cells and on cells in the tumor’s surroundings.

A phase 3 trial is currently enrolling patients to evaluate the combination vs doxorubicin plus placebo in participants with advanced or metastatic soft tissue sarcoma, including those with leiomyosarcoma and liposarcoma. The primary endpoint is overall survival and the estimated final data collection date for that outcome measure is April 2019.

Patients in the double-blind study will be randomly assigned to receive doxorubicin 75 mg/m² intravenously on day 1 of each 21-day cycle for 8 cycles plus placebo or olaratumab 20 mg/kg intravenously on days 1 and 8 of cycle 1 and 15 mg/kg intravenously on days 1 and 8 of cycles 2 through 8, followed by 15 mg/kg intravenously on days 1 and 8 of each subsequent cycle until disease progression or unacceptable toxicity.

Reference

1. FDA grants Priority Review for Lilly’s olaratumab, an investigational medicine for advanced soft tissue sarcoma [news release]. Indianapolis, IN: Eli Lilly and Company; May 4, 2016. https://investor.lilly.com/releasedetail.cfm?ReleaseID=969023. Accessed May 4, 2016.