The International Myeloma Foundation Says Thalidomide Approval in Europe Could Provide Survival Benefits to Newly Diagnosed Myeloma Patients



    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.