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Patients undergo pre-operative chemotherapy followed by surgery to resect the bone tumor and then receive post-operative chemotherapy. While receiving post-operative chemotherapy, patients also are given the immune therapy intravenously twice a week for three months and then once a week for six months. The chemotherapy acts like a bomb sent in to destroy the tumor, while MEPACT acts as a special forces unit sent in to clean out any remaining pockets of microscopic disease.

"Relapsed osteosarcoma is often resistant to chemotherapy," says Kleinerman. "By giving MEPACT to newly diagnosed patients, we hope to prevent relapse by taking care of any remaining tumor cells after chemotherapy."

Currently, only relapsed pediatric patients with osteosarcoma are able to receive treatment with MEPACT through compassionate use in the United States. MEPACT was granted orphan drug status in the United States in 2001 but has not been approved by the Food and Drug Administration for use in newly diagnosed patients. Orphan drug status is given to therapeutic agents that target rare diseases as an incentive for pharmaceutical companies to manufacture these agents.

"We have been working with this therapy for more than two decades, so getting approval in Europe is a huge milestone for those of us fighting pediatric cancer," says Kleinerman. "This drug has made significant strides for long-term survival of children with osteosarcoma."

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