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Novartis recently announced that the U.
Previously, the FDA has granted Kymriah the Regenerative Medicine Advanced Therapy (RMAT) designation for the treatment of r/r FL; the European Commission (EC) has granted Kymriah the Orphan Drug Designation (ODD) for the treatment of FL
Kymriah is a CD19-directed genetically modified autologous T cell immune cell therapy
Kymriah is the first CAR-T cell therapy approved by the US FDA.
This new indication application is based on the positive data of the key Phase 2 ELARA trial
Note: The original text has been deleted
Original source: Novartis receives priority review by US FDA and filing acceptance by EMA for Kymriah® to treat patients with relapsed or refractory follicular lymphoma