THE INTERNATIONAL MYELOMA FOUNDATION SAYS POMALIDOMIDE APPROVAL IN EUROPE ADDRESSES CRITICAL NEED FOR MORE TREATMENT OPTIONS FOR PATIENTS
--Pomalidomide (IMNOVID® in Europe; POMALYST® in the U.S.) Is Approved for Patients in Europe and the U.S. Who Have Had Multiple Prior Treatments--
--IMF Calls for Rapid Reimbursement Approvals throughout the EU--
North Hollywood, CA, August 12, 2013 -- The International Myeloma Foundation (IMF) – improving the quality of life of myeloma patients while working toward prevention and a cure – today applauded European approval of pomalidomide, the newest drug for multiple myeloma treatment. Pomalidomide (IMNOVID® in Europe and POMALYST® in the U.S.) is an IMiDs® compound, an immunomodulatory agent taken as an oral medication. The European Medicines Agency (EMA) has granted marketing authorization of pomalidomide for patients who have exhausted other treatment options.
“It is vital that we keep delivering new treatment options to myeloma patients because remissions are not a cure and previous treatments often stop working,” said Brian G.M. Durie, M.D., Chairman and Co-founder of the IMF. “We must ensure that patients have access to innovative therapies, such as pomalidomide, that have been shown to extend remissions when available options run out. We are working to find a cure for myeloma, but in the meantime we are pleased to see new innovative treatments spreading to patients worldwide.”
Pomalidomide attacks myeloma in multiple ways, fighting the cells directly, as well as stimulating the immune system to aid cancer cell destruction. In a recent Phase III clinical study, it increased survival when measured against a comparison regimen.
“Now that the EMA has recognized the clinical benefits of pomalidomide, we must work toward swift reimbursement approvals throughout Europe to make pomalidomide available to patients,” said Susie Novis, President and Co-founder of the IMF. “We understand the need among patients in Europe, and through the IMF’s global advocacy arm, are working to ensure the best outcomes possible for patients there and around the world.”
Pomalidomide is the first new myeloma drug approved in Europe since REVLIMID® (lenalidomide) was approved in 2007. The IMF also applauds the EMA’s recent expanded approval of VELCADE® (bortezomib), which is now approved for previously untreated myeloma patients before stem cell transplantation.
The IMF recently launched its Black Swan Research Initiative® to not only begin to cure myeloma, but to develop a way to determine the efficacy of new drugs in months rather than years. This could speed global approval of new drugs, and lower the cost of bringing a drug to market. Pomalidomide has been available in the U.S. since February, and another new drug, KYPROLIS® (carfilzomib), has been available in the U.S. for just over a year.
Myeloma, also called multiple myeloma, is a cancer of cells in the bone marrow that affects production of red cells, white cells and stem cells and can damage bone. It is growing in numbers and affecting increasingly younger people.
ABOUT THE INTERNATIONAL MYELOMA FOUNDATION
Celebrating its 22nd anniversary, the International Myeloma Foundation reaches 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.
CONTACT: Deanne Eagle