New data support third indication for Kymriah

4 August 2020

Swiss pharma giant Novartis (NOVN: VX) today announced positive results from the Phase II ELARA trial of Kymriah(tisagenlecleucel) in patients with relapsed or refractory (r/r) follicular lymphoma (FL).

At the interim analysis, the global study met its primary endpoint of complete response rate (CRR), as assessed by independent review committee. CRR is a standard measure of patient response to therapy in FL. No new Kymriah safety signals were observed.

Results from the ELARA trial will be presented at an upcoming medical meeting and pave the way for regulatory submissions for the new indication, with filing in the USA, where Kymriah was granted Regenerative Medicine Advanced Therapy (RMAT) status, anticipated in 2021 and in the European Union thereafter.

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