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REVLIMID® APPROVAL FOR MYELOMA CAN BE LIFE-CHANGING FOR CANCER PATIENTS
06.29.06

Targeted Therapies Helping to Manage Blood Cancers as Chronic, Long-term Illnesses

The International Myeloma Foundation – supporting research and providing education, advocacy and support for myeloma patients, families, researchers and physicians - today said FDA approval of REVLIMID® (lenalidomide) for patients with myeloma is a major new addition to the group of treatments that together have the potential to significantly extend patients' lives. REVLIMID was approved by the Food and Drug Administration in December to treat certain patients with a malignant blood condition called MDS. The supplementary approval of REVLIMID (in combination with a steroid, dexamethasone) for myeloma patients who have relapsed after at least one prior therapy provides them with a targeted, oral treatment that can be used in combination regimens and in sequence with other treatments to help keep many patients alive, active, productive, and feeling well.

Myeloma, also called multiple myeloma, is a cancer of the bone marrow that affects production of red cells, white cells and stem cells. It is the second largest of the blood cancers, affects an estimated 750,000 people worldwide, and in industrialized countries it is growing in number and affecting increasingly younger people. REVLIMID along with THALOMID® becomes the second FDA approved therapy this year from the Celgene Corporation specifically indicated for the treatment of multiple myeloma. The use of these therapies in combination regimens shows promise and innovation in dramatically changing the outlook for these patients.

Michael Tuohy, father of two young children in Connecticut was just 36 years old when he was diagnosed six years ago: "Treatments worked at first, but myeloma inevitably comes back. My doctor told me that REVLIMID was my best option for treatment that would also allow me to maintain a good quality of life, and he got me on REVLIMID in a clinical trial last November. Today I'm in complete remission, and I'm looking forward to celebrating my 42nd birthday with my wife and children next month, a milestone I was afraid I'd never see."

There is no cure for myeloma, and until the use of stem cell (bone marrow) transplants and the novel treatments that began with THALOMID (thalidomide), patients were given a poor prognosis with only three to five years life expectancy. But at a major global cancer conference earlier this month, researchers said that newly diagnosed myeloma patients treated with REVLIMID plus a steroid (dexamethasone) showed no disease progression during the course of the study, and even patients who had stopped responding to previous treatments showed improved survival with the Revlimid-steroid regimen.

"REVLIMID is an important addition to the drugs we use for myeloma and gives us an important new option when patients come out of remission," says Brian G.M. Durie, M.D., Los Angeles hematologist and chairman of the International Myeloma Foundation. "By using drug regimens in sequence, we have kept some of our patients alive and feeling well for 10,12, and in some cases more than 15 years. These new options are truly changing the way we think about myeloma, about blood cancers, and perhaps about other cancers in the foreseeable future."

REVLIMID is an oral medication taken as a pill at home. It is called a targeted therapy because it attacks the cancer without the ravages usually associated with chemotherapy. REVLIMID belongs to a new class of drugs called IMiDs, immunomodulatory drugs, developed by Celgene based on the company's work with thalidomide. It is covered by most Medicare plans.

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 (800) 452-CURE. The global Website is www.myeloma.org with a companion Website in Spanish at www.myelomala.org.


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