FDA Grants Advaxis’ Immunotherapy Drug Fast Track Status

The FDA has awarded fast track designation to Advaxis’ investigational immunotherapy ADXS-HER2 to treat patients with newly diagnosed, non-metastatic, surgically resectable osteosarcoma.

The candidate is being developed to target HER2-expressing cancers, such as breast, gastric, esophageal and osteosarcoma cancers. ADXS-HER2 is being studied as a monotherapy in a Phase 1b trial. It received orphan designation from the FDA and EMA.