FDA grants priority review to Kymriah for advanced follicular lymphoma
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The FDA granted priority review to tisagenlecleucel, a chimeric antigen receptor T-cell therapy, for treatment of adults with relapsed or refractory follicular lymphoma who received two prior lines of therapy.
Tisagenlecleucel (Kymriah, Novartis) — developed by Novartis in collaboration with University of Pennsylvania — is an autologous, gene-edited, CD19-directed CAR T-cell therapy.
The agent is 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.
Novartis submitted a supplementary biologics license application for the relapsed or refractory follicular lymphoma indication.
The FDA previously granted its regenerative medicine advanced therapy designation to tisagenlecleucel for this indication. The regenerative medicine advanced therapy program, part of the 21st Century Cures Act, aims to expedite review of regenerative medicine therapies intended to treat, modify, reverse or cure serious or life-threatening diseases or conditions.
The FDA based the priority review and regenerative medicine advanced therapy designations on results of the phase 2 ELARA trial.
An interim analysis showed the study met its primary endpoint of complete response rate as assessed by an independent review committee. No cases of grade 3 or higher cytokine release syndrome had been reported among trial participants following tisagenlecleucel infusion.
More recent results presented at TCT Meetings Digital Experience showed an overall response rate of 82.7% (95% CI, 69.7-91.8), with a complete response rate of 65.4% (99.5% CI, 45.1-82.4) among the first 52 patients eligible for efficacy analysis. Median follow up for efficacy was 9.9 months (range, 6-15.6).
“This is an important milestone in our mission to bring Kymriah to adult patients with relapsed or refractory follicular lymphoma,” Jeff Legos, PhD, executive vice president and global head of oncology and hematology development at Novartis, said in a company-issued press release. “With Kymriah demonstrating impressive results in the ELARA trial, we are hopeful that we can offer a unique and potentially definitive treatment that minimizes the burden.”
References:
Fowler NH, et al. Abstract 78. Presented at: The 2021 TCT Meetings Digital Experience (virtual meeting); Feb. 8-12, 2021.
Novartis announces Kymriah meets primary endpoint at interim analysis of pivotal study in follicular lymphoma. https://www.novartis.com/news/media-releases/novartis-announces-kymriah-meets-primary-endpoint-interim-analysis-pivotal-study-follicular-lymphoma. Published Aug. 4, 2020. Accessed Oct. 27, 2021.
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