Kymriah, a CAR-T cell therapy, was approved by the Food and Drug Administration for the treatment of patients with pretreated, relapsed/refractory follicular lymphoma.
The Food and Drug Administration (FDA) approved the CAR-T cell therapy Kymriah (tisagenlecleucel) for adults with relapsed/refractory follicular lymphoma who have received at least two lines of systemic therapy.
The approval is based off findings from the phase 2 ELARA trial, which included 90 patients who were followed up for about 17 months. Findings showed that 86% of patients who were treated with Kymriah responded to therapy, whereas 68% had a complete response, meaning that there was no detectable traces of cancer after the patient was treated.
“Patients with follicular lymphoma who relapse or don’t respond to treatment have a poor prognosis and may face a series of treatment options without a meaningful, lasting response,” Dr. Stephen J. Schuster, the Robert and Margarita Louis-Dreyfus Professor in Chronic Lymphocytic Leukemia and Lymphoma in the Division of Hematology Oncology and the director of the Lymphoma Program and Translational Research at the University of Pennsylvania’s Abramson Cancer Center, said in a press release. “This new, effective option for patients with follicular lymphoma may offer long-term benefit.”
A prolonged benefit was seen in the group that received Kymriah, as 85% of patients who achieved a complete response were still in response 12 months later.
Regarding safety and side effects, all CAR-T cell therapies carry a risk of cytokine release syndrome, where the body releases too many inflammatory molecules called cytokines, as well as neurotoxicity. Fifty-three percent of patients experienced cytokine release syndrome, though there were no high-grade (grade 3 or worse) instances of cytokine release syndrome. Additionally, 43% of patients experienced a neurologic event, with 6% experiencing high-grade neurotoxicity.
The FDA granted Kymriah a priority review in October 2021. Now, in accordance with the agency’s Accelerated Approval Program, continued approval is contingent upon results from confirmatory trials.
“The approval of Kymriah offers patients with relapsed or refractory follicular lymphoma a new treatment option and new hope for improving patient outcomes,” said Meghan Gutierrez, CEO of the Lymphoma Research Foundation, in the release. “Having this single infusion treatment option helps to transform the way healthcare providers approach this type of blood cancer and we commend those who have contributed to the acceleration of scientific research for the benefit of patients.”
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