India, April 30 -- OS Therapies, Inc. (OSTX) said the European Medicines Agency has initiated a rolling review of its Conditional Marketing Authorization (CMA) application for OST-HER2, an immunotherapy designed to prevent or delay recurrence in patients with fully resected pulmonary metastatic osteosarcoma. The company called the regulatory progress a major step toward potential early market access in Europe.
Pulmonary metastatic osteosarcoma is an aggressive form of bone cancer that often spreads to the lungs, where recurrence after surgery remains a significant clinical challenge. OST-HER2 is a gene-edited, listeria-based cancer immunotherapy engineered to stimulate a targeted immune response against HER2-expressing tumor cells.
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