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

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Ref: bluebird bio | Image: BMS