The International Myeloma Foundation Says Positive Recommendation by Regulatory Body Brings Myeloma Patients in Europe Closer to Accessing Latest Treatment

The International Myeloma Foundation (IMF) – improving the quality of life of myeloma patients while working toward prevention and a cure – today said the newest drug for treating multiple myeloma could be available to patients in Europe within the next few months. Pomalidomide (POMALYST® in the U.S.) is an IMiDs® compound, an immunomodulatory agent taken as an oral medication. It was approved by the U.S. Food and Drug Administration in February of this year for patients who have exhausted other treatments. Now, a positive opinion from the European Union’s Committee for Medicinal Products for Human Use (CHMP) could set the stage for Pomalidomide approval in Europe within the next few months.

“We believe patients should have access to the best treatments no matter where they live,” said Susie Novis, President and Co-founder of the IMF. “Through our global advocacy arm and our research efforts with the International Myeloma Working Group, we are working to ensure the best outcomes possible for patients around the world.”

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. Pomalidomide is the first new therapeutic approved for patients with multiple myeloma since KYPROLIS® (carfilzomib) was FDA approved in the U.S. in July 2012, and the first oral cancer agent for myeloma patients since REVLIMID® was approved by the FDA in June 2006 and by the EMA in June 2007.

Brian G.M. Durie, M.D., Chairman and Co-founder of the IMF, noted, “We are working to develop a cure for myeloma, but in the meantime patients need a pipeline of innovative therapies such as Pomalidomide, KYPROLIS and other new drugs. These therapies have been shown to extend remissions for patients when all of the previous options stop working. We are eager to see these innovations spread to patients worldwide.”

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.

The IMF leadership will be in Europe in mid-June for a summit meeting of the International Myeloma Working Group, the European Hematology Association Conference, and presentation of the Robert A. Kyle Lifetime Achievement Award for 2013.

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.