- Patients, Advocates and Experts Applaud Positive Opinion from
EU Advisory Committee---
NORTH HOLLYWOOD, CA/BRUSSELS, Belgium, March 23 /CNW/ -- 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(R) (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 Wuerzburg, 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 Neuchatel in Switzerland, is an oral medication
belonging to a new class of immunomodulatory drugs called IMiDs(R). When
approved it will join the other novel therapies including Thalomid
(thalidomide) also from Celgene and distributed by Pharmion in Europe, and
Velcade (bortezamib) 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
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(R), a unique gene bank to advance myeloma
research. The IMF can be reached at +1-818-487-7455. The global Website is
www.myeloma.org with a companion Website in Spanish at www.myelomala.org.
Stephen Gendel of BioCom Partners, New York +1-212-918-4650
(*) U.S., incidence, National Cancer Institute
For further information:
For further information: Stephen Gendel of BioCom Partners,
+1-212-918-4650 Web Site: http://www.myeloma.org, http://www.myelomala.org