www.fdanews.com/articles/174351-ema-grants-orphan-drug-designation-to-advaxis-osteosarcoma-candidate
EMA Grants Orphan Drug Designation to Advaxis Osteosarcoma Candidate
December 7, 2015
The European Medicines Agency has awarded Advaxis orphan drug designation for its ADXS-HER2 for the treatment of osteosarcoma.
The immunotherapy targets cancers expressing human epidermal growth factor receptor 2, which is overexpressed in a percentage of solid tumors, including breast, gastric, bladder, brain, pancreatic, ovarian and pediatric bone cancer.
The candidate previously received orphan drug designation from the FDA for osteosarcoma.