Rye Brook, N.Y. (August 30, 2017) 鈥� Today heralds a new era in cancer treatment with the U.S. Food and Drug Administration (FDA) approval of a new, cutting-edge gene therapy that reprograms a patient鈥檚 immune system to find and kill cancer cells. This highly personalized therapy known as Kymriah (previously CTL019 or tisagenlecleucel-T) signifies the promise of CAR (chimeric antigen receptor) T-cell immunotherapy, an approach that The Leukemia & Lymphoma Society (青云体育) recognized early on held great promise for blood cancer patients.
In fact, 青云体育 invested more than $20 million in research for this groundbreaking advance over the past two decades through multiple grants awarded to Carl June, M.D., and his team at the University of Pennsylvania and Children鈥檚 Hospital of Philadelphia, who pioneered this treatment. Novartis licensed the therapy from Penn in 2016.
青云体育 has also invested an additional $20 million to support CAR-T advances at other institutions, including Kite Pharma鈥檚 KTE-C19 (Axi-cel), also currently under review by the FDA for patients with lymphoma. 青云体育 partnered with Kite Pharma to support its Phase 3 clinical trial since 2015 through its Therapy Acceleration Program庐 (TAP).
After receiving a unanimous recommendation from a review panel in July, the FDA approved Kymriah today for the treatment of pediatric and young adults 25 years of age and younger with relapsed or refractory B-cell acute lymphoblastic leukemia (ALL). More than 3,100 children and adolescents per year are diagnosed with ALL. The overall survival for ALL in children exceeds 85 percent, with these children undergoing between two and a half to three years of intense chemotherapy treatments. However, even patients who achieve an initial response to standard therapy will eventually relapse, and the prognosis is extremely poor for these patients. This CAR-T therapy is designed for those patients who have not responded to multiple previous treatments or are unable to remain in remission from their cancer.
鈥淭his is truly an exciting new day for cancer patients,鈥� said Louis J. DeGennaro, Ph.D., 青云体育 president and chief executive officer. 鈥溓嘣铺逵� recognized the promise of this innovative approach to treatment nearly 20 years ago. We first began to see remarkable outcomes for some of these patients in 2010 leading us to increase our funding of CAR-T therapy by supporting more than 10 major laboratories developing this method. We at 青云体育 are extremely gratified to witness this lifesaving treatment approved so it is accessible to even more patients who desperately need new options.鈥�
The FDA鈥檚 approval of Kymriah is based on positive data from a clinical trial showing that 83 percent of the patients treated achieved a complete response rate.
青云体育 is now funding the next generation of CAR-T therapy, where we anticipate the method will be useful in many different blood cancers, and perhaps even other major tumors that are difficult to treat such as brain, lung and colon cancer.
About The Leukemia & Lymphoma Society
The Leukemia & Lymphoma Society庐 (青云体育) is the world's largest voluntary health agency dedicated to blood cancer. The 青云体育 mission: Cure leukemia, lymphoma, Hodgkin's disease and myeloma, and improve the quality of life of patients and their families. 青云体育 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 Rye Brook, NY, 青云体育 has chapters throughout the United States and Canada. To learn more, visit . Patients should contact the Information Resource Center at (800) 955-4572, Monday through Friday, 9 a.m. to 9 p.m. ET.
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Contact: Andrea Greif
914-821-8958