Novartis Reports the US FDA and EMA's Acceptance of sBLA for Kymriah (tisagenlecleucel) and Granted Priority Review to Treat R/R Follicular Lymphoma
Shots:
- The submissions are based on the P-II ELARA trial evaluates the efficacy and safety of Kymriah in adult patients with r/r FL after at least two prior therapies over 30 sites in 12 countries globally
- The trial met its 1EPs i.e., the therapy showed a robust response in heavily pretreated patients & the safety profile was remarkable & no patient experienced =Gr-3 CRS within the 1st 8wks.
- Currently, the therapy is approved by multiple regulatory authorities for pediatric & adult patients aged 25yrs. with ALL & for r/r adult DLBCL. Kymriah has previously received ODD from the EC for FL
Ref: Novartis | Image: Novartis
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