Rye Brook, N.Y. (May 2, 2018) – The latest approval of a game-changing personalized cancer therapy on Tuesday is further proof of the promise of immunotherapy, an approach that The Leukemia & Lymphoma Society (LLS) supported early on and which holds great promise for blood cancer patients, as well as for patients with other types of cancers.
The U.S. Food and Drug Administration (FDA) granted tisagenlecleucel (Kymriah®) its second approval to treat patients with diffuse large B-cell lymphoma (DLBCL) whose cancer had worsened or returned despite two or more more earlier treatments. Kymriah was approved in August 2017, by the FDA for patients with another type of blood cancer, acute lymphoblastic leukemia, who are 25 or younger. The first approval heralded the arrival of a new era in cancer treatment.
The rapidly emerging immunotherapy approach, known as CAR (chimeric antigen receptor) T-cell immunotherapy, uses genetic engineering to reprogram the patient’s own immune T cells to find and kill cancer cells. These engineered T cells persist in the patient’s blood stream, continuing on as a living drug.
“Immunotherapy is dramatically changing the way we approach blood cancer treatment,” said Louis J. DeGennaro, Ph.D., LLS president and chief executive officer. “These approvals are a testament to the fact that breakthroughs in blood cancer research are saving lives. CAR-T is already being tested in gliobastoma, pancreatic and ovarian cancer, and while challenges remain, we expect to see progress on these other cancers in the near future.”
Yesterday’s approval marks the second CAR-T approved for lymphoma patients. The FDA approved another CAR-T, axicabtagene ciloleucel (Yescarta ®), in October 2017, for treatment of patients with relapsed or refractory DLBCL, the most common type of non-Hodgkin lymphoma (NHL), which impacts approximately 2,500 patients in the U.S. each year.
According to DeGennaro, “For the past two decades, LLS has invested more than $40 million in CAR-T research and development. More than half of these funds supported nearly two decades of work on CAR-T at the University of Pennsylvania through LLS’s research grants programs, resulting in the development of Kymriah. Beginning in 2015, LLS also supported the clinical trial leading to the approval of Yescarta through our Therapy Acceleration Program® (TAP). Through TAP, LLS partners directly with biotechnology companies, including the developer of Yescarta, Kite, a Gilead Company, to help accelerate the development of promising treatments.”
Both therapies are also approved for DLBCL arising from follicular lymphoma (transformed follicular lymphoma or tFL). Yescarta is additionally approved for primary mediastinal large B-cell lymphoma (PMBCL).
Non-Hogdkin lymphoma is a blood cancer that impacts the lymphatic system. DLBCL is a particulary aggressive lymphoma, where the 5-year overall survival rate is approximately 60% and many patients present with advanced disease at the time of diagnosis. Patients with relapsed or refractory aggressive NHL have a particularly poor prognosis. These approvals bring a new option to patients who do not respond to standard therapies.
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 Rye Brook, 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.