IDM Pharma, Inc. has received a not approvable letter from the United States Food and Drug Administration (FDA) for their investigational drug mifamurtide (L-MTP-PE) – formerly Junovan – for the treatment of osteosarcoma.
IDM Pharma, Inc. filed a new drug application (NDA) for mifamurtide for the treatment of non-metastatic osteosarcoma; mifamurtide received orphan drug designation in 2001. The not approvable letter contained a request by the FDA for additional clinical trials to demonstrate the potential benefits of mifamurtide.
Timothy Walbert, CEO and President of IDM Pharma stated that “while the FDA has asked for data from additional clinical trials, we believe that this decision was made in context of the lack of complete data in the submitted NDA and that capturing supplemental data will overcome the need for additional trials and further confirm the overall survival benefit of L-MTP-PE in osteosarcoma and provide evidence for approvability."
Mifamurtide is an immune-stimulatory agent that directs the immune system to attack cancer cells.
© 1998-2007 OncoEd.com All Rights Reserved.
These materials may discuss uses and dosages for therapeutic products that have not been approved by the United States Food and Drug Administration. All readers should verify all information and data before administering any drug, therapy or treatment discussed herein. Neither the editors nor the publisher accepts any responsibility for the accuracy of the information or consequences from the use or misuse of the information contained herein.
Patient Home
