|[February 08, 2013]
Multiple Myeloma Research Foundation (MMRF) Celebrates the FDA Accelerated Approval of Pomalyst® (pomalidomide) for the Treatment of Relapsed and Refractory Multiple Myeloma
NORWALK, Conn. --(Business Wire)--
The Multiple Myeloma Research Foundation (MMRF) today joined the
multiple myeloma community in celebrating the U.S. Food and Drug
Administration's (FDA) decision to grant accelerated approval of Pomalyst®
(Celgene Corporation, pomalidomide) for the treatment of patients with
relapsed and refractory multiple myeloma who no longer respond to
currently available treatments. A critical advance for the treatment of
this incurable blood cancer, together with KyprolisTM
(carfilzomib), Pomalyst marks the second treatment to receive
accelerated approval in the last seven months, which is unparalleled in
any other cancer.
"Today marks another historic day - the availability of an unprecedented
second breakthrough therapy for this fatal disease within just seven
months for patients who have run out of treatment options," stated Kathy
Giusti, Founder and CEO of the MMRF and the Multiple Myeloma Research
Consortium (MMRC), and a multiple myeloma patient. "We are grateful for
the FDA's decision and for the unwavering commitment of our partner
Celgene to the multiple myeloma patient community, and are proud to have
accelerated the development of this promising new treatment."
In 2008, the MMRC entered into collaboration with Celgene and bolstered
the clinical development of Pomalyst. Since that time, the MMRC:
Facilitated the Phase I and Phase II clinical trials that provided the
basis for the accelerated approval, which included assistance with
protocol development and Institutional Review Board (IRB) submissions.
Drove rapid patient enrollment to the Phase I and Phase II
registration trials, enrolling 100% of patients in the Phase I trial
and more than80% in the Phase II trial, completing enrollment in less
than two years and exceeding timeline expectations by several months.
Provided dedicated site management and guidance on key safety and
efficacy issues throughout the Phase I and Phase II registration
Supported further investigation of Pomalyst for multiple myeloma; to
date, the MMRC has opened four trials involving pomalidomide, two of
which are novel combinations that are currently open for enrollment.
Pomalyst was approved by the FDA for patients who have received at least
two prior therapies including Revlimid® (lenalidomide) and
Velcade® (bortezomib) and have demonstrated disease
progression on or within 60 days of completion of the last therapy, and
will only be available in the United States through POMALYST REMS™, a
restricted distribution program.
About the Multiple Myeloma Research Foundation (MMRF)
The Multiple Myeloma Research Foundation (MMRF) was established in 1998
as a 501(c)(3) non-profit organization by twin sisters Karen Andrews and
Kathy Giusti, soon after Kathy's diagnosis with multiple myeloma. The
mission of the MMRF is to relentlessly pursue innovative means that
accelerate the development of next-generation multiple myeloma
treatments to extend the lives of patients and lead to a cure. As the
world's number-one private funder of multiple myeloma research, the MMRF
has raised over $200 million since its inception and directs 90% of
total budget to research and related programming. As a result, the MMRF
has been awarded Charity Navigator's coveted four-star rating for nine
consecutive years, the highest designation for outstanding fiscal
responsibility and exceptional efficiency. For more information about
the MMRF, please visit www.themmrf.org.
About the Multiple Myeloma Research Consortium
The Multiple Myeloma Research Consortium (MMRC) is a 509(a)3 non-profit
organization that integrates leading academic institutions to accelerate
drug development in multiple myeloma. It is led from MMRC offices in
Norwalk, Conn., and comprises 16 member institutions: Barbara Ann
Karmanos Cancer Institute, Baylor Charles A. Sammons Cancer Center at
Dallas, City of Hope, Dana-Farber Cancer Institute, Emory University's
Winship Cancer Institute, the John Theurer Cancer Center at Hackensack
University Medical Center, Mayo Clinic, Mount Sinai School of Medicine,
Ohio State University, Sarah Cannon Research Institute, University
Health Network (Princess Margaret Hospital), University of
California-San Francisco, University of Chicago, University of Michigan,
Virginia Cancer Specialists, and Washington University in St. Louis.
The MMRC is the only consortium to join academic institutions through
membership agreements, customized IT systems, and an integrated tissue
bank. For more information, please visit www.themmrc.org.
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