—POMALYST Is the First Therapeutic Approved for Myeloma Patients in 2013 and the First New Immunomodulatory Drug since 2006 with Approval Anticipated in Europe Later This Year—
North Hollywood, CA, February 08, 2013 – The International Myeloma Foundation (IMF) – the oldest and largest foundation dedicated to improving the life and care of myeloma patients – said POMALYST® (pomalidomide) approval by the U.S. Food and Drug Administration will provide an important new option for patients who have exhausted all other treatments. POMALYST is an IMiDs® compound, an immunomodulatory agent taken as an oral medication. It attacks the cancer in multiple ways, fighting the cells directly, as well as stimulating the immune system to aid cancer cell destruction. POMALYST is the first new oral cancer therapeutic approved for patients with multiple myeloma since REVLIMID® was approved by the FDA in June 2006.
The FDA decision follows the recent approval of KYPROLIS®, a second-generation proteasome inhibitor for myeloma patients who have relapsed after previous therapies. In clinical trials, POMALYST and KYPROLIS also work together as a powerful new combination regimen.
Brian G.M. Durie, M.D., Chairman and Co-founder of the IMF, states, “With the novel therapies, many patients can experience long-term remissions. Since their introduction more than ten years ago, the median survival rate has increased from three years to nearly ten years because of these advances produced through medical innovation. However, when current drugs stop working, patients who’ve been through the full arsenal of available treatments need a powerful new therapeutic. POMALYST meets that need because it works after stem cell transplant or even after resistance has developed to other IMiDs therapies and proteasome inhibitors.”
POMALYST is approved for use in relapsed/refractory myeloma patients along with low-dose dexamethasone. In a recent Phase III clinical study, it increased survival when measured against a comparison regimen.
Myeloma patient Paula Van Riper of New Jersey has been on POMALYST in clinical trials since 2010. She says, “I’ve had multiple myeloma for 13 years, and throughout that time I’ve led an active life. I’ve been through just about every drug for myeloma, so the availability of POMALYST not only allowed me to stay in remission, it enabled me to continue to work, feel good, and live the life I want to lead despite having cancer.”
The timeline for the novel therapies dates back to 2003 with the introduction of the proteasome inhibitor VELCADE®. In 2006 THALOMID® and REVLIMID were approved; in 2012 a second-generation proteasome inhibitor, KYPROLIS, was approved; and now POMALYST joins this important group in the U.S.
“I knew things were about to change dramatically back in 1999 when I was talking to Celgene's founder Sol Barer at the International Myeloma Workshop in Stockholm. He discussed very exciting updates on oral immunomodulatory therapies to combat multiple myeloma. That was the first hint of what would become the novel therapies," said Susie Novis, President and Co-Founder of the IMF. "Now, as we mark the approval of POMALYST, we could not have imagined how far we would come with five new drugs in our armamentarium! The IMF is proud of our active role in moving these important novel therapies forward.”
Ms. Novis added: “We continue to advance our own exciting research initiatives, and encourage companies and academic centers to continue theirs as well. A key IMF initiative is the work we do to ensure that patients have access to these latest treatments."
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. POMALYST was submitted to the European Medicines Agency for approval in Europe and a decision is expected in the second half of 2013.
ABOUT THE INTERNATIONAL MYELOMA FOUNDATION
Celebrating its 22nd 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.
CONTACT: Deanne Eagle