The International Myeloma Foundation Says Newly Diagnosed Patients Could Benefit From FDA "Priority Review" Of VELCADE(R) For Front-Line Use

Main Category: Cancer / Oncology
Article Date: 06 Feb 2008 - 3:00 PDT

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The International Myeloma Foundation (IMF) - supporting research and providing education, advocacy and support for myeloma patients, families, researchers and physicians - said the FDA decision granting "priority review" for VELCADE(R) in newly diagnosed myeloma recognizes the benefits of powerful new therapies and the need to get them to more patients sooner.

VELCADE (bortezomib) is already approved for myeloma patients who have received at least one prior therapy. Priority status accelerates official FDA review for newly diagnosed patients from ten months to six months, which means VELCADE could be approved for expanded use this June.

Myeloma, also called multiple myeloma, is a cancer of the bone marrow that affects production of red cells, white cells and stem cells. VELCADE along with what are called the other novel therapies, thalidomide and REVLIMID®, have changed the outlook for myeloma patients, but only thalidomide (THALOMID® in the U.S.) has been approved for newly diagnosed patients. Unofficially, many doctors are already using the novel therapies for the full range of patients, based on clinical data and on approval by the Compendia, the listings that help authorize insurance reimbursement.

"This May will mark the fifth anniversary of VELCADE approval, and it is fitting to consider expanding its use at this time," said Susie Novis, president and co-founder of the IMF. "An FDA review will provide important assurances of the benefits of VELCADE for the newly diagnosed, and should encourage more doctors to use it in this important patient group."

VELCADE for injection is the first in a new class of medicines called proteasome inhibitors that disrupt the life cycle of a cancer cell. More than 85,000 patients have been treated with VELCADE worldwide.

About The International Myeloma Foundation

The International Myeloma Foundation is the oldest and largest myeloma organization, reaching more than 165,000 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 International Myeloma Foundation