Shots: Shots:

• The US FDA has granted RMAT designation to Novartis’ Kymriah (tisagenlecleucel) to treat patients with r/r FL. The designation is based on P-II ELARA study evaluating the efficacy and safety of tisagenlecleucel in adult patients with r/r FL
• The RMAT designation supports the advancement of Kymriah and reflects the unmet need for patients with r/r follicular lymphoma. Novartis has developed Kymriah in collaboration with the Perelman School of Medicine at the University of Pennsylvania
• Kymriah is designed to be a one-time treatment and is the first FDA-approved CAR-T cell therapy- indicated for r/r ALL in pediatric & adult patients and r/DLBCL in adults. Novartis anticipates the US regulatory filing of Kymriah in 2021

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