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EU approves VELCADE for all stages of multiple myeloma
Source: (cancerfacts.com)
Tuesday, September 09, 2008
HIGH WYCOMBE, England – Sept. 9, 2008 – The European Commission has approved VELCADE® in combination with melphalan and prednisone for the first-line treatment of patients with multiple myeloma who are not eligible for high-dose chemotherapy with bone marrow transplant. The approval was announced today by Janssen-Cilag / Ortho Biotech the biotech partnership that is marketing the drug in Europe.
In 2005, VELCADE was approved in the European Union for multiple myeloma after first relapse. VELCADE as a treatment by itself has already been approved in 87 countries for the treatment of multiple myeloma patients who have relapsed and, or did not respond to other treatments.
This approval for frontline treatment is based on phase III results from the VISTA trial, recently published in the New England Journal of Medicine, which demonstrated statistically superior results across all effectiveness measures compared to melphalan and prednisone. In particular, complete response (CR) rates were similar to those that have been achieved in the transplant setting. VISTA stands for: VELCADE as Initial Standard Therapy in Multiple Myeloma: Assessment with melphalan and prednisone results.
"VELCADE has already made an important contribution for patients with multiple myeloma at first relapse," said Professor Jesus San Miguel, M.D., University of Salamanca in Spain, the principal investigator for the VISTA trial. "The marketing authorization from the EMEA is encouraging as it suggests that more patients may benefit from earlier treatment."
Multiple myeloma is the second most common blood cancer, representing approximately one percent of all cancers and two percent of all cancer deaths. In 2002, there were approximately 85,700 cases of multiple myeloma worldwide. Currently, only 30 percent of MM patients survive longer than five years with more than 18,000 people in the European Union dying each year from the disease.
VELCADE is the first proteasome inhibitor to receive worldwide regulatory approval for the treatment of multiple myeloma. Proteasome inhibitors are drugs that block the action of large protein complexes, called proteasomes. These enzymes break down proteins, like the p53, a key component in the regulation of cell division. When P53 is mutated, cells in many types of tissues become unregulated and divide out of control.
Clinical trials are underway to investigate the potential of VELCADE in additional settings and in combination with other anti-cancer drugs to enhance treatment effects or reverse resistance.
The most common side effects reported with VELCADE include fatigue, gastrointestinal adverse events, transient loss of blood-clotting platelet cells and nerve effectiveness neuropathy, which is reversible in the majority of patients.
SOURCE: news release issued by Janssen-Cilag / Ortho Biotech via PRNewswire.
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