--The European Commission Grants Marketing Authority for Melphalan-Prednisone-Thalidomide Regimen--
North Hollywood, California, USA and Würzburg, Germany, April 21, 2008 -- The International Myeloma Foundation—conducting research and providing education, advocacy, and support for myeloma patients, families, researchers, and physicians worldwide—today said the European Commission has approved the use of a thalidomide regimen in patients newly diagnosed with multiple myeloma, a cancer in the bone marrow that affects production of blood cells and stem cells. Although the drug has a controversial history, thalidomide has powerful anti-cancer properties and has been transformed into one of the most widely prescribed treatments for myeloma in the United States, where it was approved in May 2006. In Europe thalidomide as a component of a combination regimen has been approved with appropriate safeguards, and is especially important in myeloma patients who cannot tolerate stem cell transplants, a standard of care in younger patients.
"This is an important milestone that has the potential to extend lives and improve the quality of life for myeloma patients in Europe," said Susie Novis, president and co-founder of the IMF. "The 'novel therapies' including REVLIMID® and VELCADE® have had an important positive impact on myeloma patients who have relapsed after other treatments, but thalidomide* is the first of this group of drugs to be approved in newly diagnosed patients in the US and in Europe."
In Europe newly diagnosed myeloma has been treated with a combination of two drugs, melphalan and prednisone. Recent studies showed that adding thalidomide to that regimen (MPT) increased average survival to more than four years. The MPT regimen has also shown the longest time to progression in myeloma patients of any melphalan-prednisone combination to date at 28 months, according to a 2007 Lancet publication. The combined use of MPT was developed by two doctors at the University of Torino, Mario Boccadoro, M.D., and Antonio Palumbo, M.D.
"This is an oral regimen that gave us a faster response, more complete remissions and nearly doubled the duration of remissions," said Dr. Palumbo. "In addition we are looking into other opportunities using the novel therapies in combination with melphalan and prednisone, and we expect to have results of our studies combining REVLIMID with melphalan-prednisone in the near future."
Thalidomide was first tested in multiple myeloma in 1997. Within a year it became recognized as the most promising new agent for multiple myeloma at the time, and thalidomide remains an essential part of both the treatment regimen and research into the underlying mechanisms of blood and related cancers. It will be prescribed along with a risk management plan that includes a number of steps intended to prevent pregnancies in women being treated with thalidomide. In the United States there have been more than 100 thousand thalidomide prescriptions written under the S.T.E.P.S.® risk-management program without a single incident of birth defects being reported.
*Thalidomide is marketed for multiple myeloma as THALOMID® in the US and Thalomid Pharmion™ in Europe
ABOUT The International Myeloma Foundation
The International Myeloma Foundation is the oldest and largest myeloma organization, reaching more than 165,000 members in 113 countries worldwide. A 501 (c) 3 non-profit organization dedicated to improving the quality of life of myeloma patients and their families, the IMF focuses in four key areas: research, education, support and advocacy. To date, the IMF has conducted more than 100 educational seminars worldwide, maintains a world-renowned hotline, and operates Bank on a Cure®, a unique gene bank to advance myeloma research. The IMF can be reached at (800) 452-CURE. The global Website is www.myeloma.org with a companion Website in Spanish at www.myelomala.org.
Patients and physicians: Media:
International Myeloma Foundation Stephen Gendel and Jennifer Anderson
800-452-2873 +1 212 918 4650