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
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
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
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.
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