This accelerated FDA approval is the first CAR T-cell therapy approved for the treatment of patients with indolent follicular lymphoma.
Kite Pharma announced that Yescarta (axicabtagene ciloleucel) has been granted accelerated approval by the Food and Drug Administration (FDA) for the treatment of adults with relapsed or refractory follicular lymphoma after receiving two or more lines of systemic therapy.
This accelerated approval is the first chimeric antigen receptor (CAR) T-cell therapy approved for patients with indolent (or low-grade) follicular lymphoma, according to a news release from the company. This disease is a type of non-Hodgkin lymphoma that can become more aggressive over time. It affects an estimated 22% of patients who receive a diagnosis of lymphoma worldwide. Before this approval, options were limited with regards to treating patients with relapsed or refractory indolent follicular lymphoma who were treated with at least two lines of therapy.
The approval was based on findings from the ZUMA-5 study, which demonstrated that 91% of patients with relapsed or refractory follicular lymphoma responded to Yescarta. In addition, 74% of patients were in continued remission at 18 months. Median duration of response, or the amount of time a tumor responds to treatment without disease growth or spread, was not achieved in patients with follicular lymphoma during a median follow-up of 14.5 months,
“Once a follicular lymphoma patient’s disease relapses, the duration of response to care shortens with each round of therapy,” said Dr. Caron A. Jacobson, medical director of the Immune Effector Cell Therapy Program at Dana-Farber Cancer Institute and assistant professor of medicine at Harvard Medical School, in the release. “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.
In the ZUMA-5 study, some severe or life-threatening side effects were observed including cytokine release syndrome (an inflammatory response from factors such as infection) in 8% of patients with neurologic toxicities in 21% of patients. Prescribing information for Yescarta features a warning for these risks.
“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, chief executive officer of Kite, said in the release. “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, PhD, chief scientific officer of The Leukemia & Lymphoma Society, in the release. “(The Leukemia & Lymphoma Society) 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.”
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