Novartis Reports Results of Kymriah (tisagenlecleucel) in P-II ELARA Study for Follicular Lymphoma
Shots:
- The P-II ELARA study involves assessing the efficacy and safety of Kymriah in adult patients with r/r FL across 12 countries in 30 sites globally
- At the interim analysis- the study met its 1EPs of CRR- as assessed by IRC. The company will include the results in regulatory submissions- with anticipated filing to the US FDA in 2021- and then in EU- while the results will be presented at an upcoming medical meeting
- Kymriah has received FDA’s RMAT designation in r/r FL based on preliminary ELARA trial findings- reflecting the unmet need for additional treatment options for FL. The Therapy was developed in collaboration with the Perelman School of Medicine at the University of Pennsylvania
Ref: Novartis | Image: Novartis
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