FDA Approves Second LLS-Supported CAR T-cell Immunotherapy

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Rye Brook, N.Y. (October 18, 2017) – The Leukemia & Lymphoma Society (LLS) hails today’s U.S. Food and Drug Administration (FDA) approval of a new, personalized cell therapy that supercharges the patient’s immune system to find and kill cancer cells. The therapy, axicabtagene ciloleucel (Yescarta ™), is the second of this new method of treatment, known as CAR (chimeric antigen receptor) T-cell immunotherapy, to receive FDA approval for blood cancer patients in the past six weeks, and the first to treat patients with lymphoma.

LLS has supported the clinical trial leading to the approval of Yescarta since 2015 through its 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.

The FDA’s approval of Yescarta is for treatment of patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), the most common type of non-Hodgkin lymphoma (NHL), and several more rare types including primary mediastinal large B-cell lymphoma (PMBCL), high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma (transformed follicular lymphoma or tFL). Non-Hodgkin lymphoma is a blood cancer that impacts the lymphatic system. More than 25,000 people in the United States are expected to be diagnosed with DLBCL in 2017. 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. This approval brings a new option to patients who do not respond to standard therapies.

The approval is based on positive data from the LLS-supported clinical trial showing that 51 percent of the patients treated in the study had complete response with no detectable cancer remaining.

“Immunotherapy is dramatically changing the way we approach blood cancer treatment, and we are hopeful that this therapy will ultimately be applicable to patients with other types of cancers as well,” said Louis J. DeGennaro, Ph.D., LLS president and chief executive officer. “LLS is committed to supporting the development of potentially curative therapies for patients diagnosed with blood cancers, and we identified Kite’s CAR T-cell therapy as having great potential for patients with lymphoma who have limited treatment options. Today’s approval is a very significant advance for lymphoma patients and for the cancer community as a whole.”

CAR T personalized cellular therapy is a revolutionary approach to treating cancer by using genetic engineering to reprogram the patient’s own immune T cells to find and kill cancer cells. For the past two decades, LLS has invested more than $40 million in CAR T research and development. More than half of the funds supported nearly two decades of work on CAR T at the University of Pennsylvania through its research grants programs. That therapy, tisagenlecleucel-T (Kymriah TM), licensed by Novartis, received FDA approval on August 30 for patients with relapsed or refractory B-cell acute lymphoblastic leukemia (ALL), another type of blood cancer.

Yescarta is also the second therapy funded through LLS’s TAP to receive FDA approval in just the past two months. The FDA approved another TAP-supported therapy, Vyxeos™, on August 3, to treat patients with a high-risk subtype of acute myeloid leukemia (AML), another type of blood cancer. That therapy was developed by TAP partner Celator Pharmaceuticals, which was acquired by Jazz Pharmaceuticals in May 2016. These advances are a significant achievement for LLS’s venture philanthropy model, launched a decade ago

Stemline, another LLS TAP partner, has a therapy in the pipeline for patients with a rare blood cancer called blastic plasmacytoid dendritic cell neoplasm (BPDCN). This therapy received breakthrough status from the FDA in August 2016, based on promising response data and is on track for filing for review by the FDA later this year or early next year.

Click here to read more about Yescarta and click here to learn more about CAR T-cell immunotherapy.

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.

For additional information visit lls.org/lls-newsnetwork. Follow us on Facebook, Twitter, and Instagram.

Contact:

Andrea Greif

andrea.greif@lls.org

914-821-8958

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