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

(White Plains, NY) - February 12, 2014 – 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 ImbruvicaTM, 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.