--New Indication Provides Treatment-Free Interval As an Option--
North Hollywood, CA, June 23, 2008 - The International Myeloma Foundation (IMF)—supporting research and providing education, advocacy and support for myeloma patients, families, researchers and physicians—today applauded the decision by the US Food and Drug Administration (FDA) to expand the benefits of VELCADE® (bortezomib) for injection to a wider range of multiple myeloma patients. Since 2003, VELCADE has been approved for relapsed patients who have had at least one prior therapy. The FDA has now granted the use of VELCADE to previously untreated patients with multiple myeloma.
The VELCADE approval is based on positive data from the international VISTA trial of VELCADE administered with melphalan and prednisone (VcMP) compared to melphalan and prednisone (MP) alone. According to Millennium Pharmaceuticals, The Takeda Oncology Company, this is the largest ever Phase III clinical trial in newly diagnosed multiple myeloma patients. VELCADE is the first in a new class of medicines called proteasome inhibitors that disrupt the life cycle of a cancer cell. It is currently being co-developed by Millennium Pharmaceuticals, and Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Susie Novis, president and co-founder of the IMF, says, "The VELCADE front-line FDA nod of approval is very good news. VELCADE, along with the other 'novel therapies,' THALOMID® and REVLIMID®, is radically changing the way physicians look at treating myeloma."
In 2007, there were approximately 20,000 newly diagnosed multiple myeloma patients in the US, according to Brian G.M. Durie, MD, internationally recognized multiple myeloma expert and co-founder, chairman, and medical director of the IMF.
Dr. Durie explains, "As patients live longer they will need more drugs available in combination and sequence. With the new approval, doctors now have the confidence of FDA support when they offer eligible newly diagnosed patients VELCADE as an induction therapy."
Multiple myeloma is a cancer of the bone marrow that impacts the 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 numbers as well as in increasingly younger people.
On news of the FDA's decision to expand the benefits of VELCADE to a wider range of multiple myeloma patients, Beth Faiman RN, MSN, a nurse practitioner at the Cleveland Clinic and a member of the IMF Nurse Leadership Board, explained, "A diagnosis of multiple myeloma is life altering, daunting and ripe with worry. Knowing that patients have a wider spectrum of therapeutics that have the FDA 'stamp of approval' makes me more hopeful that this disease is moving toward becoming a chronic diagnosis with new chances for improved overall survival."
The International Myeloma Foundation is the oldest and largest myeloma organization, reaching more than 180,000 members in 113 countries worldwide. www.myeloma.org
. ABOUT The International Myeloma Foundation
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 1-818-487-7455. The global website is www.myeloma.org
with a companion website in Spanish at www.myelomala.org
CONTACT: Peggy Frank, 818 735 3591