North Hollywood, CA, USA, and Brussels, Belgium March 23, 2007 - The International Myeloma Foundation (IMF)—supporting research and providing education, advocacy and support for myeloma patients, families, researchers and physicians—today applauded the positive opinion from the European Union's Committee for Medicinal Products for Human Use (CHMP) recommending approval of REVLIMID® (lenalidomide) for patients with myeloma. REVLIMID is the newest of a group of treatments together called novel therapies that are changing the course of treatment for myeloma, the second most common of the blood cancers*. The positive recommendation from CHMP suggests REVLIMID could be approved for availability by prescription in Europe within the next few months. REVLIMID is approved in the United States for certain patients with myeloma and a malignant blood condition called myelodysplastic syndromes, MDS.
"REVLIMID has changed my outlook on life," said Vincent Brix of France who was diagnosed with myeloma in 2002 when he was 40 years old. "The initial treatments for my disease were harsh, and with chemotherapy and then two bone marrow transplants, I came out of remission. Then last year I was able to get REVLIMID, and now I can live normally again. I simply feel reborn."
Myeloma, also called multiple myeloma, is a cancer of the bone marrow that affects production of red cells, white cells and stem cells. It affects an estimated 750,000 people worldwide, and in industrialized countries it is being diagnosed in growing in numbers and in increasingly younger people. There is no cure, but by using REVLIMID and other therapies in combination and sequentially doctors are moving myeloma toward becoming a chronic disease.
"Data from clinical trials of REVLIMID as well as our own experience using it here in Europe is impressive," said Prof. Dr. Hermann Einsele, a member of the IMF Scientific Advisory Board, who has worked with REVLIMID in clinical trials as director of the University Clinic of Würzburg, Germany. "In recent studies reported at international medical meetings, newly diagnosed myeloma patients treated with REVLIMID plus a steroid (dexamethasone) showed very good response during the course of the study, and even patients who had stopped responding to previous treatments showed improved survival with the REVLIMID-steroid regimen."
"While most cancer treatment benefits are measured in months, we are seeing many of our patients experience long-term responses measured in years and achieved without the ravages of chemotherapy," said Susie Novis president and co-founder of the IMF. "Global approval and availability of REVLIMID is essential for our patients."
REVLIMID from the Celgene Corporation with headquarters in New Jersey in the United States and Neuchâtel in Switzerland, is an oral medication belonging to a new class of immunomodulatory drugs called IMiDs®. When approved it will join the other novel therapies including Thalomid (thalidomide) also from Celgene and distributed by Pharmion in Europe, and Velcade (bortezomib) from Millennium.
"Drugs like REVLIMID are important because they have multiple mechanisms of action that don't just poison cells like traditional chemotherapy, but attack the factors that allow the cancer to thrive as well as the environment in which the cancer cells live," said Brian G. M. Durie, M.D., myeloma specialist and chairman and co-founder of the International Myeloma Foundation. "This means we are able to increase the efficacy of our treatments, decrease their side effects, and apply them to a growing range of cancers."
IMF activities planned in Europe this year include Patient and Family Seminars in France and Italy in September, Spain in October and Germany in November, as well as participation in medical meetings in Greece, Russia and Austria where a special lifetime achievement award will be given to Dr. Heinz Ludwig of Vienna in June.
ABOUT The International Myeloma Foundation
The International Myeloma Foundation is the oldest and largest myeloma organization, reaching more than 135,000 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 on 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 +1818-487-7455. The global Website is www.myeloma.org with a companion Website in Spanish at www.myelomala.org.
*U.S. incidence, National Cancer Institute
Stephen Gendel, BioCom Partners, New York
+1 212 918 4650