Kite wins FDA OK for new indication for Yescarta
Kite, a Gilead Company has received the green light from the Food and Drug Administration for Yescarta (axicabtagene ciloleucel) for the treatment of adult patients with relapsed or refractory follicular lymphoma, or FL after two or more lines of systemic therapy. The approval makes Yescarta the first chimeric antigen receptor (CAR) T-cell therapy approved for patients with indolent follicular lymphoma, and marks the third approved indication for a Kite cell therapy.
“Once a follicular lymphoma patient’s disease relapses, the duration of response to care shortens with each round of therapy,” said Caron Jacobson, medical director, Immune Effector Cell Therapy Program, Dana-Farber Cancer Institute and assistant professor of Medicine, Harvard Medical School. “Additionally, for follicular patients in the third line of therapy, the five-year survival rate is only 20%, highlighting the urgent need for treatments that offer a real chance for durable remission. Impressively, 91% of follicular lymphoma patients in the ZUMA-5 study responded to a single infusion of axicabtagene ciloleucel, including an estimated 74% of patients in a continued remission at 18 months, giving these patients much-needed hope and oncologists an important addition to the treatment armamentarium.”
“As we look to bring the hope of survival to more patients in need, today’s FDA decision represents a real step forward in our commitment in hematologic malignancies,” said Christi Shaw, Kite CEO. “Advancing CAR T therapies for patients across lymphomas remains a cornerstone of our cell therapy development program, and we are excited about the potential of Yescarta for patients with indolent follicular lymphoma.”
“This is an important new treatment option for people with third-line relapsed or refractory follicular lymphoma,” said Lee Greenberger, chief scientific officer of The Leukemia & Lymphoma Society. “LLS has supported CAR T development from the beginning, and on behalf of blood cancer patients, we thank Kite and Gilead for their work in bringing this remarkably innovative treatment to more patients.”
Yescarta also is indicated for the treatment of: adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma, or DLBCL not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma; and adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.