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IMF LOOKS FORWARD TO RAPID REVIEW OF REVLIMID FOR MYELOMA PATIENTS FOLLOWING FDA APPROVAL FOR MDS
12.28.05
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Patients and physicians Media:
International Myeloma Foundation GendeLLindheim BioCom Partners
818-487-7455 Stephen Gendel
212-918-4650

New Drug Approved for Blood Disorder Also Demonstrates Positive Results in Myeloma Clinical Trials

North Hollywood, CA, December 28, 2005 -- The International Myeloma Foundation – supporting research and providing education, advocacy and support for myeloma patients, families, researchers and physicians - today said it anticipates rapid review of Revlimid (lenalidomide) for patients with myeloma, also called multiple myeloma, a cancer of bone marrow cells that causes an estimated 60,000 deaths each year. Revlimid from the Celgene Corporation was just approved by the Food and Drug Administration to treat certain patients with a malignant blood condition called MDS. However, the Foundation noted that in phase III clinical studies Revlimid has also demonstrated efficacy in myeloma patients, including those who have relapsed following other treatments.

“Revlimid showed outstanding results* in a recent trial involving patients who have exhausted all other treatment options,” said Susie Novis, president of the International Myeloma Foundation. “We are available to support rapid review of Revlimid for myeloma, and we are working on behalf of patients to help with pre-approval access to the drug for those who may desperately need it now.”

Revlimid is an anti-cancer drug that can be taken by mouth. Other newer drugs used to treat myeloma include Velcade from Millennium Pharmaceuticals and Thalomid also from Celgene.

“Revlimid will be a much needed addition to our potent but small arsenal for use in myeloma, especially for patients who no longer respond to available treatments or who cannot tolerate the side effects of existing drugs,” said Brian G. M. Durie, M.D., chairman of the board of the International Myeloma Foundation. “My own clinical experience has already shown that the addition of Revlimid as a treatment option in certain specific cases allows us to significantly extend lives and move myeloma closer to becoming a chronic disease, where patients can pursue active lives while keeping their symptoms under control.”

“What I read about myeloma indicated that I might have only three to five years to live, but here I am alive and feeling good a full seven years after my initial diagnosis with multiple myeloma,” said Allan Bailey of Houston, Texas, who was first diagnosed with a precursor of multiple myeloma (MGUS) in 1989 and with cancer in 1998. “For the past two years I¹ve been on Revlimid, and based on my own experience, I would like to see its potential extended to all patients who would benefit from new therapies.

Myeloma is a potentially fatal bone marrow cancer that affects production of red cells, white cells and stem cells, and afflicts an estimated 250,000 people worldwide. Symptoms included fatigue and weakness, bone damage, kidney damage and susceptibility to infection.

About the IMF

The International Myeloma Foundation is the oldest and largest myeloma organization reaching more than 125,000 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 or www.myeloma.org.

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*a statistically significant improvement in time to disease progression – the primary endpoint of this type of trial


Read Celegene's Press Release concerning the approval of Revlimid

Read the FDA's statement about the approval of Revlimid

Get more information about Revlimid


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