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FDA grants fast track designation to ADXS-HER2 for osteosarcoma

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The FDA granted fast track designation to ADXS-HER2 for treatment of newly diagnosed, nonmetastatic, surgically resectable osteosarcoma, according to a press release from the agent’s manufacturer.

ADXS-HER2 (Advaxis) —an immunotherapy product developed to target HER-2–expressing cancers — alters a live strain of Listeria monocytogenes bacteria to generate cancer-fighting T cells, according to the release. The T cells then are directed against a cancer antigen, as well as neutralizing factors that protect the tumor microenvironment from immunologic attack.

“We are pleased that the FDA has granted this important designation for ADXS-HER2,” Daniel O’Connor, CEO of Advaxis, said in the press release. “There are limited therapeutic treatment options available for this patient population, with no new treatments approved in over 20 years.”

The FDA and European Medicines Agency granted orphan drug designation to ADXS-HER2 last year for the treatment of osteosarcoma. The agent has demonstrated efficacy in canine osteosarcoma, which serves as a model for the malignancy in humans.