North Hollywood, CA, June 21, 2012—The International Myeloma Foundation (IMF)—the oldest and largest foundation dedicated to improving the life and care of myeloma patients—says patients backed by leading medical experts are pressing for access to much-needed new therapies as drug and drug-use submissions meet with different responses from regulatory bodies this week.
“In myeloma patients resistance to current drugs develops, and without new drugs—and new ways to use existing drugs—patients with a deadly disease can be left with no options,” says Susie Novis, President and Co-founder of the IMF. “Current drugs have made a dramatic improvement in the length and quality of life for patients, but we have yet to find a cure, making new treatments essential.”
In the U.S. an FDA advisory panel showed strong support for carfilzomib despite safety concerns after an impassioned plea by IMF representatives including myeloma patient Michael Tuohy: "Side effects don't scare me. I can deal with them. The alternative is death."
However, in Europe an EMA decision about approval of REVLIMID in newly diagnosed patients and for maintenance use, has been delayed while regulators wait for longer-term follow-up from studies in this setting.
Brian G.M. Durie, M.D., Chairman and Co-founder of the IMF says this points to the need for a new approach to evaluating treatment options. “Studies show REVLIMID maintenance demonstrated unprecedented progression free survival, PFS. This means patients live better. We believe it is also an indication that patients will live longer, a trend we are seeing already with this treatment. We hope regulators will gain confidence in the value of long-term progression free survival in deciding about new treatment regimens.”
Regarding a third drug, pomalidomide, a new drug application has been accepted by the FDA in the U.S., and a similar application for pomalidomide has been submitted to the EMA in Europe. Both carfilzomib, to be marketed as KYPROLIS, and pomalidomide would be used for patients after multiple previous therapies have stopped working. They could become the first new drugs approved for myeloma in six years.
Myeloma, also called multiple myeloma, is a cancer of cells in the bone marrow that affect the immune system and can damage bone. It is increasing in numbers and is becoming more common in younger patients with possible links to environmental toxins. Recently, myeloma was added to the list of cancers covered in people exposed to the aftermath of the 9/11 terror attacks.
ABOUT THE INTERNATIONAL MYELOMA FOUNDATION
Celebrating its 21st anniversary, the International Myeloma Foundation is the oldest and largest myeloma organization, reaching more than 215,000 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 250 educational seminars worldwide, maintains a world-renowned hotline, and established the International Myeloma Working Group (IMWG), a collaborative research initiative focused on improving myeloma treatment options for patients. The IMF can be reached at (800) 452-CURE (2873). The global website is www.myeloma.org.