Breakthrough CAR-T Immunotherapy Approved

FDA approval of Yescarta for treating Non-Hodgkin’s Lymphoma brings personalized immunotherapy to the frontlines of care.

The FDA approved Kite’s YescartaTM (axicabtagene ciloleucel), the first chimeric antigen receptor T cell (CAR-T) therapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell non-Hodgkin lymphoma (DLBCL) after two or more lines of systemic therapy.

The hematologic cancer treatment acquires an individual patient’s T-cells, engineers them outside the body and “tunes” them for optimum performance to seek out and destroy cancer cells. “The FDA approval of Yescarta is a landmark for patients with relapsed or refractory large B-cell lymphoma,” said Kite Founder, Arie Belldegrun. “This approval would not have been possible without the courageous commitment of patients and clinicians, as well as the ongoing dedication of Kite’s employees,” he acknowledged, pointing out the role of regulators as well, saying “We must also recognize the FDA for their ability to embrace and support transformational new technologies that treat life-threatening illnesses. We believe this is only the beginning for CAR-T therapies.”

According to Kite, DLBCL is the most common aggressive non-Hodgkin lymphoma, accounting for three out of every five cases in the U.S. annually. Those treated with the current standard of care historically have had a median six-month survival rate with very few attaining a complete response. According to the company, there are approximately 7,500 patients with refractory DLBCL who are eligible for CAR-T therapy.

“With CAR-T therapy, we are reengineering a patient’s own immune system to detect and kill cancer cells, and the results have been impressive,” said Frederick L. Locke, ZUMA-1 Co-Lead Investigator and Vice Chair of the Department of Blood and Marrow Transplant and Cellular Immunotherapy at Moffitt Cancer Center in Tampa, Florida. “Many of the patients that received CAR-T therapy had already relapsed several times with traditional treatments such as chemotherapy or hematopoietic stem cell transplant. Now, thanks to this new therapy many patients are in remission for months.”

Yescarta will be produced at Kite’s commercial manufacturing facility in El Segundo, California, where in its ZUMA-1 pivotal trial, the company says it demonstrated a 99% success rate in manufacturing the therapy, with a median turnaround time of 17 days.

 

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