www.fdanews.com/articles/176563-fda-awards-lillys-olaratumab-priority-review
FDA Awards Lilly’s Olaratumab Priority Review
May 10, 2016
The FDA has granted priority review to Eli Lilly’s combination-candidate olaratumab and doxorubicin for treatment of advanced soft tissue sarcoma that does not respond to radiotherapy or surgery.
Olaratumab already has received breakthrough therapy, fast track and orphan drug-status for the same indication.
The FDA’s decision was based on a Phase 2 trial that compared the olaratumab/doxorubicin combination to doxorubicin alone.