Logo

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

Share this

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

Click here to­ read the full press release 

Senior Editor

This content piece was prepared by our former Senior Editor. She had expertise in life science research and was an avid reader. For any query reach out to us at connect@pharmashots.com

Share this article on WhatsApp, LinkedIn and Twitter

Join the PharmaShots family of 12000+ subscribers

I accept the Terms and Conditions