Osteosarcoma is a childhood cancer, usually affecting the bones of children and young adults during adolescent growth spurts. Most of the tumors are found in large bones such as the femur, tibia and humerus, though the tumors can occur in any bone. Although fewer than 1,000 new cases are diagnosed in the U.S. each year, the survival rate of children with osteosarcoma has remained at 60-65 percent since the 1980s.
IDM Pharma Inc. (Nasdaq: IDMI) concentrates on developing innovative cancer products that destroy cancer cells by activating immunity or preventing tumor recurrence. The company focuses on reaching full therapeutic and commercial potential for each of its products, including its resectable osteosarcoma treatment.
The company today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) released a positive review of IDM’s L-MTP-PuE, or MEPACT, to treat resectable osteosarcoma. The committee also recommended that IDM receive authorization for centralized marketing of L-MTP-PuE in Europe through the European Commission. The company anticipates approval in early 2009.
Timothy P. Walbert, president and CEO of IDM, said the positive opinion will help IDM launch L-MTP-PuE into the market, benefiting the company as well as cancer patients and their families.
“The recommendation for approval by the CHMP is a great victory for many young patients and their families and is a significant step for the company in bringing this important treatment to market,” Walbert stated in the press release. “The committee’s decision validates the clinical trial data and the belief of investigators, patients and IDM Pharma that L-MTP-PE provides a significant overall survival benefit for osteosarcoma patients and meets a significant unmet treatment need.”
Centralized marketing authorization will allow for the exclusive marketing of L-MTP-PuE for 10 years in the 27 Member States of the European Union, as well as in Iceland, Liechtenstein and Norway. This will mark the first approved new treatment for osteosarcoma in more than 20 years.
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