(White Plains, NY) - July 23, 2014 - Today's U.S. Food and Drug Administration (FDA) approval of idelalisib to treat patients with relapsed chronic lymphocytic leukemia (CLL), follicular lymphoma (FL) and small lymphocytic lymphoma (SLL) is a significant advance for patients with these blood cancers.
Idelalisib, which goes by the trade name Zydelig (R), is a first-in-class inhibitor of PI3K delta, a protein that is highly expressed in many B-cell malignancies and plays a critical role in the viability, proliferation and migration of these cancer cells.
Idelalisib is an oral therapy indicated in combination with rituximab, a monoclonal antibody, for patients with relapsed or refractory CLL for whom rituximab alone would be considered appropriate therapy. In October 2013, a Phase 3 study evaluating idelalisib in combination with rituximab in previously-treated CLL patients not fit for standard chemotherapy was stopped early because interim analysis was showing significant improvement in median progression-free survival as well as median overall survival compared to placebo plus rituximab.
Idelalisib was also approved today as a monotherapy for patients with relapsed FL and SLL who have received at least two prior systemic therapies. FDA granted accelerated approval for FL and SLL based on overall response rate.
"We have been eagerly awaiting the approval of this therapy as these are patients for whom there are few other good treatment options," said Lee Greenberger, Ph.D., LLS's chief scientific officer. "LLS funded research contributed to the understanding of the PI3K pathway in B-cell malignancies beginning in 1999; this allowed the identification and clinical development of inhibitors of this target. 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."
About The Leukemia & Lymphoma Society
The Leukemia & Lymphoma Society (R) (LLS) is the world's largest voluntary health agency dedicated to blood cancer. The LLS mission: Cure leukemia, lymphoma, Hodgkin's disease and myeloma, and improve the quality of life of patients and their families. LLS funds lifesaving 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 9 p.m. ET.