For Immediate Release
Contact: Andrea Greif
Senior Director of Communications
(914)821-8958 (p)
914)772-3027 (c)
andrea.greif@lls.org
White Plains, NY (December 3, 2014) - Today's U.S. Food and Drug Administration (FDA) approval of blinatumomab to treat patients with an uncommon form of acute lymphoblastic leukemia is a significant advance for patients with this form of blood cancer.
The FDA approval is for patients with Philadelphia chromosome-negative (PH-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). These patients have a poor prognosis and few treatment options.
The therapy had received the FDA's Breakthrough Therapy designation in July 2014. It was approved today under the FDA's accelerated approval program. Continued approval for this indication may be contingent upon verification of clinical benefit in subsequent trials.
Blinatumomab, which will be marketed in the U.S. with the trade name BlincytoTM, is a bispecific antibody T-cell engager (BiTE®), which works by directing the body's immune T cells to the CD 19 protein found on the surface of all B cells, including B-cell leukemias and lymphomas. The modified antibodies are designed to engage two different targets (one on the B cell and one on the T cell) simultaneously, thereby connecting the T cells (white blood cells capable of killing other cells) to the cancer cells.
Blinatumomab is the first single-agent immunotherapy to be approved for the treatment of patients with Philadelphia chromosome-negative relapsed or refractory B-cell precursor ALL.
"There is a critical need for new treatment options for patients with Philadelphia chromosome-negative, relapsed or refractory ALL, and the approval of blinatumomab is the first major treatment advance in more than two decades for these patients," said Louis J. DeGennaro, Ph.D., LLS president and chief executive officer. "We have been eagerly awaiting new treatment options for these patients. LLS is funding research to advance other types of bispecific antibodies, and this approach shows potential efficacy for other types of cancers as well, including a novel bispecific antibody for the treatment of Hodgkin lymphoma that is currently funded by LLS's Therapy Acceleration Program. LLS exists to find cures and ensure access to treatments for blood cancer patients, and another promising new advance that brings the potential to help save more lives is good news for the patients we serve."
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, 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.