WHITE PLAINS, N.Y., Nov. 4, 2013 /PRNewswire/ -- The U.S. Food and Drug Administration's approval of Gazyva® (obinutuzumab) is an important advance for patients diagnosed with chronic lymphocytic leukemia (CLL).
Gazyva, the first treatment approved through the FDA's breakthrough therapy designation, is indicated in combination with chlorambucil to treat previously untreated patients with CLL. Breakthrough therapy designation is granted if preliminary clinical evidence indicates the drug may offer a substantial improvement over available therapies for patients with serious or life-threatening diseases, and the FDA deems that it warrants expedited development.
Gazyva is an antibody that binds to the CD20 protein expressed on the surface of all B cells, which are immune cells present in many forms of cancer. Once bound to these cells, Gazyva causes cancer cells to die by engaging the patient's own immune system.
"Gazyva plus chlorambucil showed significant positive results in its Phase 3 clinical trial compared to those patients who received only chlorambucil. This rapid approval is good news for many patients diagnosed with CLL for whom there are limited effective options," said Lee Greenberger, chief scientific officer of The Leukemia & Lymphoma Society (LLS). "LLS exists to find cures and ensure access to treatments for all blood cancer patients, and we applaud this new advance that brings the potential to help save more lives. In securing the first breakthrough therapy designation, this approval is yet another example of how blood cancer research is leading the way in bringing innovative cancer therapies to patients. In fact, approximately half of the new cancer drugs approved by the FDA between 2000 and 2012 were first approved for a blood cancer. "
Breakthrough therapy designation is granted if preliminary clinical evidence indicates the drug may offer a substantial improvement over available therapies for patients with serious or life-threatening diseases, and the FDA deems that it warrants expedited development.
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 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 6 p.m. ET.
Contact: Andrea Greif
SOURCE The Leukemia & Lymphoma Society