FDA grants Advaxis fast track designation for ADXS-HER2 for patients with newly-diagnosed, non-metastatic osteosarcoma

28 April 2016 -  Advaxis today announced that the FDA has granted Fast Track Designation for the company’s immunotherapy product candidate ADXS-HER2 for patients with newly-diagnosed, non-metastatic, surgically-resectable osteosarcoma.

Advaxis’ investigational immunotherapies, including ADXS-HER2, are designed to capitalize on the body’s ability to recognize and attack bacterial infections. Advaxis’ core technology – Lm Technology – alters a live strain of Listeria monocytogenes (Lm) bacteria to generate cancer fighting T-cells directed against a cancer antigen and neutralizing factors that protect the tumor microenvironment from immunologic attack and contribute to tumor growth.

ADXS-HER2 received orphan drug designation in 2015 from the FDA and EMA for the treatment of osteosarcoma.

For more details, go to: http://ir.advaxis.com/press-releases/detail/1219

Michael Wonder

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Michael Wonder

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Cancer , Medicine , Fast track