The U.S. Food and Drug Administration (FDA) today announced its approval for a breakthrough treatment that will bring the promise of immunotherapy and new hope to thousands of patients diagnosed with mantle cell lymphoma (MCL) whose previous treatments fail to bring them lasting remissions.
There are more than 70 subtypes of lymphoma, and MCL is a particularly aggressive form of this blood cancer with a short remission from standard therapies. The median overall survival rate is between four and five years, but once a patient relapses from chemotherapy or BTK-targeting therapies such as ibrutinib or acalabrutinib, the prognosis is very poor with anticipated survival of perhaps only a year or less.
This latest approval, for brexucabtagene autoleucel, (formerly KTE-X19, now branded as Tecartus ™) is the first chimeric antigen receptor (CAR) T-cell therapy approved for patients with MCL. As we’ve described multiples times in this blog, CAR T-cell therapy is a revolutionary treatment approach that genetically engineers patients’ immune T cells and reintroduces them into the body through a one-time infusion to kill cancer cells. When the therapy works, the T cells continue to expand in the body and persist indefinitely, keeping the cancer at bay.
Tecartus is developed by Kite, A Gilead Company. LLS first partnered with Kite Pharma in 2015 through our Therapy Acceleration Program (TAP) to support its CAR-T trials. LLS’s support helped with trials for other types of lymphoma, but our funding helped lay the foundation to enable CAR-T therapies to tackle multiple types of blood cancers. Overall LLS has invested more than $50 million over two decades to advance CAR-T. . LLS continues to drive innovation for further improvements in CAR T-cell therapy through the support of many major academic medical centers including Memorial Sloan Kettering, the University of Pennsylvania, MD Anderson Cancer Center, City of Hope, Baylor College of Medicine, and the University of Colorado.
Kite previously received approval for its CAR-T, axicabtagene ciloleucel (Yescarta ™), for treatment of relapsed/refractory diffuse large B-cell lymphoma (DLBCL).
Today’s approval is based on the clinical trial (Zuma-2) in which 87 percent of the patients responded to treatment, with 62% benefiting from a complete response. These strong results offer hope that many of these patients will finally remain cancer-free for the long-term.