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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.