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: Fierce Pharma