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(R) and VELCADE(R) 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.(R) risk-management program
without a single incident of birth defects being reported.
*Thalidomide is marketed for multiple myeloma as THALOMID(R) in
the US and Thalomid Pharmion(TM) 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(R), 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.
