New CAR T-Cell Therapy Approved by the FDA for the Treatment of Patients With Relapsed or Refractory Large B-Cell Lymphoma

In October 2017, the pharmaceutical company Kite announced that the U.S. Food and Drug Administration (FDA) has granted regular approval to Yescarta™, the first chimeric antigen receptor T cell (CAR T) therapy for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy.

This new treatment gives hope to patients with relapsed or refractory large B-cell lymphoma who have run out of options after having

relapsed several times with traditional treatments such as chemotherapy or hematopoietic stem cell transplant.

CAR T therapy is a breakthrough in hematologic cancer treatment in which a patient’s own T cells are engineered to seek and destroy cancer cells. CAR T therapy is manufactured specifically for each individual patient.

Diffuse large B-cell lymphoma (DLBCL) is the most common aggressive non-Hodgkin lymphoma (NHL), accounting for three out of every five cases. In the United States each year, there are approximately 7,500 patients with refractory DLBCL who are eligible for CAR T therapy. Historically, when treated with the current standard of care, patients with refractory large B-cell lymphoma had a median overall survival of approximately six months, with only seven percent attaining a complete response. Currently, patients with large B-cell lymphoma in second or later lines of therapy have poor outcomes and greater unmet need, since nearly half of them either do not respond or relapse shortly after transplant.

Although the risks are still high with regard to cytokine release syndrome (CRS) and neurologic toxicities, with the CAR T cell therapy, the patients’ changes have been increased to be in remission for months.

The complete press release is available here.