FDA approves Kymriah for advanced follicular lymphoma
Click Here to Manage Email Alerts
The FDA granted accelerated approval to tisagenlecleucel for treatment of adults with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.
Tisagenlecleucel (Kymriah, Novartis) — developed by Novartis in collaboration with University of Pennsylvania — is an autologous, gene-edited, CD19-directed chimeric antigen receptor T-cell therapy.
The agent is also approved in the U.S. for patients aged 25 years or younger with relapsed or refractory B-cell precursor acute lymphoblastic leukemia, as well as adults with diffuse large B-cell lymphoma, high-grade B-cell lymphoma or DLBCL arising from follicular lymphoma.
Tisagenlecleucel is the second CAR T-cell therapy approved for commercial use in the U.S. for patients with relapsed or refractory follicular lymphoma. The agency previously approved axicabtagene ciloleucel (Yescarta; Kite Pharma, Gilead) — a CD19-directed CAR T-cell therapy — for the same indication in March 2021.
Continued commercial availability of tisagenlecleucel for advanced follicular lymphoma is contingent on the results of future confirmatory clinical trials, according to the requirements of the FDA’s accelerated approval program.
“The approval of Kymriah offers patients with relapsed or refractory follicular lymphoma a new treatment option and new hope for improving patient outcomes,” Meghan Gutierrez, CEO of the Lymphoma Research Foundation, said in a Novartis-issued press release. “Having this single infusion treatment option helps to transform the way [health care] 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.”
The FDA based approval on data from the phase 2 ELARA trial. The efficacy analysis included 90 patients (median age, 58 years; range 29-73; 69% male; 78% white) who received a single dose of tisagenlecleucel.
The therapy induced an 86% overall response rate among patients with relapsed or refractory follicular lymphoma, with 68% of patients remaining in complete remission as of 16.59 months of follow-up.
Safety results from the ELARA trial showed 53% of patients experienced grade 1 or grade 2 cytokine release syndrome. No patients had grade 3 or higher CRS.
Neurotoxicity occurred in 43% of study participants, with 6% experiencing grade 3 or grade 4 events.
“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,” Stephen J. Schuster, MD, director of the lymphoma program and translational research at University of Pennsylvania’s Abramson Cancer Center and principal investigator for the ELARA trial, said in the release. “This new, effective option for patients with follicular lymphoma may offer long-term benefit.”
Tisagenlecleucel will include a boxed warning that outlines risks for CRS and neurotoxicity associated with use of CAR T cells. The therapy is available only through the restricted Kymriah REMS [Risk Evaluation and Mitigation Strategy] program.
References:
Kymriah [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2022.
Novartis. FDA approves Novartis Kymriah CAR-T cell therapy for adult patients with relapsed or refractory follicular lymphoma (press release). Available at: www.novartis.com/news/media-releases/fda-approves-novartis-kymriah-car-t-cell-therapy-adult-patients-relapsed-or-refractory-follicular-lymphoma. Published May 28, 2022. Accessed May 31, 2022.
Read more about
Click Here to Manage Email Alerts