Logo

BMS and bluebird bio to Resubmit the BLA for Idecabtagene Vicleucel (ide-cel- bb2121) to Treat Patients with Multiple Myeloma

Share this

BMS and bluebird bio to Resubmit the BLA for Idecabtagene Vicleucel (ide-cel- bb2121) to Treat Patients with Multiple Myeloma

Shots: Shots:

  • The companies receive the US FDA’s Refusal to File letter regarding the BLA for idecabtagene vicleucel for patients with heavily pre-treated r/r MM- which was submitted in Mar’2020
  • Upon preliminary review- the US FDA determined that the Chemistry- Manufacturing and Control module of the BLA requires further detail to complete the review
  • Ide-cel is a BCMA-directed genetically modified autologous CAR T cell immunotherapy and has received the US FDA’s BT designation and EMA’s PRIME designation for r/r MM. Additionally- BMS to resubmit the BLA no later than the end of July 2020

Click here ­to­ read full press release/ article 

Ref: bluebird bio | Image: BMS 


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