Novartis Reports the US FDA and EMA’s Acceptance of sBLA for Kymriah (tisagenlecleucel) and Granted Priority Review to Treat R/R Follicular Lymphoma

October 29, 2021 Auto Bot EMA, FDA, Kymriah, Novartis, Priority Review, regulatory, sBLA 0

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

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