Data Monitoring Board Recommends that All Patients in Clinical Trial “Cross Over” to Active Treatment with Pomalidomide
This Is Encouraging News for Pomalidomide Approval Now Expected Early 2013 US and Second Half of 2013 EU
NORTH HOLLYWOOD, Calif.--(BUSINESS WIRE)-- The International Myeloma Foundation (IMF) – the oldest and largest foundation dedicated to improving the life and care of myeloma patients – said pomalidomide, an investigational drug for multiple myeloma, has demonstrated overall survival even in patients who have undergone multiple previous treatments. The finding came during an ongoing international clinical trial of pomalidomide when the data safety monitoring board allowed all patients in the trial to receive pomalidomide instead of just a comparison regimen.
“The improvement in overall survival in the patients in the study taking pomalidomide is being described as ‘statistically significant and clinically meaningful,’ and we believe this will further support approval of this investigational drug,” said Brian G.M. Durie, M.D., Chairman and Co-Founder of the IMF. “What is especially important to patients is that pomalidomide works even after resistance has developed to other IMiDs, proteasome inhibitors or even after stem cell transplant. Pomalidomide, alone or in powerful combinations with other drugs, will provide an important new option for patients who need new treatments.”
Pomalidomide is an experimental oral drug that attacks the cancer in multiple ways, fighting the cells directly, as well as stimulating the immune system. The US Food and Drug Administration has accepted pomalidomide for review with a decision expected no later than February 10, 2013. A decision by the EMA in Europe is anticipated later next year.
Susie Novis, President and Co-founder of the IMF noted, “This is an important time for patients with multiple myeloma. The novel therapies VELCADE® and REVLIMID® changed the course of myeloma, providing extended remissions. The recent approval of KYPROLIS® provides a new option for patients who have exhausted all other treatments, and the anticipated approval of pomalidomide further opens the door to more treatment options for patients that hopefully will provide longer remissions and a better quality of life.”
Ms. Novis added, “The IMF was instrumental in supporting approval of KYPROLIS with important patient and expert testimony. We will also work for pomalidomide approval with patient support and with research, and once it is approved, we have an active program to support insurance reimbursement for oral cancer drugs.”
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. Although multiple myeloma was once “a rare disease of the elderly,” it is affecting younger patients in greater numbers and even patients as young as those in their early twenties.
Pomalidomide is undergoing evaluation in an international phase III trial. According to the data safety monitoring board, the pomalidomide regimen met the study’s primary endpoint of progression free survival as well as overall survival, a key secondary endpoint. Approval submissions have been based on pomalidomide with low-dose dexamethasone for patients with relapsed and refractory multiple myeloma.
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.
Deanne Eagle, 917-837-5866
Source: The International Myeloma Foundation