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A drug used to treat a type of fatal bone tumour that typically affects children and young adults has been backed by Europe’s medicines watchdog.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has given the go-ahead for mifamurtide (L-MTP-PE) to be marketed throughout the European Union, Iceland, Liechtenstein and Norway.
The drug – from pharmaceutical firm IDM Pharma – is used in the treatment of patients with non-metastatic, resectable osteosarcoma.
The recommendation will be adopted at the next CHMP meeting in December with final European Commission approval expected within 60 to 90 days thereafter.
If successful, the drug will be the first approved new treatment in more than 20 years for patients with osteosarcoma.
The ruling by CHMP came after a phase III study funded by the National Cancer Institute (NCI) in cooperation with the Children’s Oncology Group (COG) found survival after six years of follow-up in patients treated with chemotherapy and L-MTP-PE was 78%, compared to 70% in patients treated with chemotherapy alone.
Timothy Walbert, president and chief executive officer of IDM Pharma, said: “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.”
Copyright Press Association 2008