FDA grants priority review to olaratumab for soft tissue sarcoma

The FDA granted priority review for olaratumab in combination with doxorubicin to treat patients with advanced soft tissue sarcoma who are not responsive to curative treatment with radiotherapy or surgery.

“We are encouraged that the FDA has granted priority review for olaratumab as a potential treatment for advanced soft tissue sarcoma,” Richard Gaynor, MD, senior vice president of product development and medical affairs for Lilly Oncology, said in a release. “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 included results from a pivotal phase 2 open-label, randomized trial that evaluated the addition of olaratumab (LY3012207, IMC-3G3; Eli Lilly and Company) — a PDGFR-alpha antagonist — to doxorubicin chemotherapy in patients with advanced soft tissue sarcoma not amenable to curative treatment with surgery or radiotherapy.

A phase 3 trial of olaratumab and doxorubicin in advanced soft tissue sarcoma is currently recruiting adult patients.

Olaratumab has been granted breakthrough therapy designation, fast track status and orphan drug designation by the FDA. The application also is currently being reviewed by the European Medical Association under an accelerated assessment schedule.