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The Leukemia & Lymphoma Society Applauds FDA's Approval of Ibrutinib for Patients with Previously Treated Chronic Lymphocytic



   The Leukemia & Lymphoma Society Applauds FDA's Approval of Ibrutinib for
        Patients with Previously Treated Chronic Lymphocytic Leukemia

CLL is second indication approved by FDA for ibrutinib; previously approved
for mantle cell lymphoma patients

PR Newswire

WHITE PLAINS, N.Y., Feb. 12, 2014

WHITE PLAINS, N.Y., Feb. 12, 2014 /PRNewswire/ -- Today's U.S. Food and Drug
Administration (FDA) approval of ibrutinib to treat patients with chronic
lymphocytic leukemia (CLL) is a significant advance for patients with this
blood cancer. 

Ibrutinib received FDA approval in November to treat patients with mantle cell
lymphoma (MCL) who had previously been treated with one prior therapy. The FDA
today announced it has approved ibrutinib to treat patients with CLL who had
received at least one prior therapy.

Ibrutinib, which goes by the trade name Imbruvica™, is a therapy that  targets
an enzyme, Bruton's tyrosine kinase (BTK), which promotes growth of  a variety
of B-cell cancers, including CLL, MCL, Waldenstrom's macroglobulinemia (WM),
follicular lymphoma, diffuse large B-cell lymphoma (DLBCL), hairy cell
leukemia (HCL) and multiple myeloma.

"After the FDA designated ibrutinib as a breakthrough therapy for patients
with certain forms of blood cancers last year, we were all hopeful that it
would only be a matter of time  before the therapy was approved to treat these
patients, for whom there are few good treatment options," said Louis J.
DeGennaro, Ph.D., LLS's interim president and CEO. "Many patients with B-cell
cancers do not respond well to standard therapies and new treatments such as
ibrutinib are urgently needed. LLS exists to find cures and ensure access to
treatments for blood cancer patients, and any new advance that brings the
potential to help save more lives is good news."

LLS funding has supported clinical trials and laboratory studies of ibrutinib
for patients with CLL, MCL and other lymphomas. John C. Byrd, M.D., of the
Ohio State University, is a world-renowned CLL expert who leads an LLS-funded
research team that has been instrumental in advancing ibrutinib. LLS-funded
researcher Jonathan Friedberg, M.D. of University of Rochester was part of a
team showing effectiveness of ibrutinib against DLBCL cells, and Peter Martin,
M.D., Weill Cornell Medical College, and colleagues have reported positive
findings from a Phase II ibrutinib trial for MCL patients. LLS-funded
researcher Jennifer Brown, M.D., Ph.D., of Dana-Farber Cancer Institute, has
also played an important role in clinical trials for ibrutinib.

LLS also helped advance another BTK inhibitor, CC-292 (formerly AVL-292),
which showed encouraging activity in an early trial for CLL and lymphoma
patients, and is now being tested in combination therapies. LLS partnered with
Avila Therapeutics through LLS's Therapy Acceleration Program, from March 2010
until Celgene Corporation acquired Avila in January 2012, bringing critical
capital and commercialization expertise to the development of this promising
agent.

About The Leukemia & Lymphoma Society
The Leukemia & Lymphoma Society® (LLS) is the world's largest voluntary health
agency dedicated to blood cancer. The LLS mission: Cure leukemia, lymphoma,
multiple myeloma, and improve the quality of life of patients and their
families. LLS funds livesaving blood cancer research around the world,
provides free information and support services, and is the voice for all blood
cancer patients seeking access to quality, affordable, coordinated care.

Founded in 1949 and headquartered in White Plains, NY, LLS has chapters
throughout the United States and Canada. To learn more, visit www.LLS.org.
Patients should contact the Information Resource Center at (800) 955-4572,
Monday through Friday, 9 a.m. to 6 p.m. ET.

Contact: Andrea Greif
Senior Director of Communications
(914)821-8958 (p)
(914)772-3027 (c)
andrea.greif@lls.org

SOURCE The Leukemia & Lymphoma Society

Website: http://www.LLS.org
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