IDM Pharma, Inc. announced that the European Commission has formally authorized MEPACTÂ® (mifamurtide, L-MTP-PE) for the treatment of patients with non-metastatic, resectable osteosarcoma, a rare and often fatal bone tumor. MEPACT can now be marketed in the 27 Member States of the European Union, as well as in Iceland, Liechtenstein and Norway.
“Today’s approval of MEPACT is a significant milestone for physicians and patients in Europe, giving them access to the first new osteosarcoma treatment option in 20 years,” commented Timothy P. Walbert, president and chief executive officer, IDM Pharma. “As our lead product candidate and first to receive approval, this is also a major milestone for IDM Pharma. We look forward to amending the New Drug Application (NDA) for mifamurtide in the United States and continuing to work toward bringing this important treatment to market in the U.S.”
The approval was based on the Phase 3 MEPACT trial (INT-0133), the largest study ever completed in osteosarcoma, enrolling approximately 800 patients. The study found that by adding MEPACT to chemotherapy, there was an approximate 30 percent decrease in the risk of death with 78 percent of patients surviving more than six years following the MEPACT treatment.
“MEPACT is the first therapy in more than 20 years to demonstrate any significant long-term survival advantage in osteosarcoma,” stated Ian Lewis, MD, Professor of Cancer Research at St. James University Hospital in Leeds, England. “The approval of MEPACT is the culmination of two decades of research and dedication to children and young adults with osteosarcoma and brings real hope for a patient population in need of an innovative treatment option for this devastating disease.”
“As an investigator who has been involved in the development of MEPACT, I am thrilled that years of hard work and commitment by researchers around the world has resulted in this positive outcome,” said Eugenie Kleinerman, MD, professor and head of the Division of Pediatrics and professor of Cancer Biology at The University of Texas M.D. Anderson Cancer Center. “This is a remarkable advance for treatment of young patients with osteosarcoma and should give physicians and their patients hope in treating this rare disease.”