FDA accepts Novartis CAR-T cell therapy Kymriah supplementary biologics license application

CompilationTom Lee

Recently, the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have respectively accepted Novartis’ Kymriah (tisagenlecleucel) as a treatment for relapsed or refractory (r/r) follicular lymphoma (FL) adults The patient’s application for review
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Previously, the U.
S.
FDA also granted priority review of the supplementary biologics license application (sBLA) for CAR-T cell therapy in this indication
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Novartis's application is based on data from the Phase II ELARA trial, which studied the efficacy and safety of Kymriah in adult r/rFL patients
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The safety results of the ELARA test showed that there was no new safety signal for Kymriah during the test
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Jeff Legos, Executive Vice President, Global Head of Oncology and Hematology Development, Novartis said, “This is an important milestone in Novartis’ mission to bring Kymriah to adult patients with relapsed or refractory follicular lymphoma.

"Legos believes that the European Union’s orphan drug designation and the FDA’s priority review emphasize the unmet clinical needs of these patients and the urgency of treatment.

However, trials of this therapy have not been smooth sailing
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