BMS and bluebird bio Report the US FDA’s Acceptance of Idecabtagene Vicleucel’s BLA for Priority Review to Treat Multiple Myeloma

Shots:

• The US FDA has accepted the PR of BLA for idecabtagene vicleucel to treat adult patients with MM prior treated with at least three therapies including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 Ab. The anticipated PDUFA date is Mar 27, 2021
• The BLA is based on a P-II KarMMa study assessing ide-cel in 128 adults with heavily pre-treated and highly refractory MM exposed to three therapies. The results of the study are presented at ASCO20
• Ide-cel is a BCMA directed genetically modified autologous CAR T cell immunotherapy and has received FDA’s BT and EMA’s PRIME designation. BMS plans regulatory submissions for ide-cel in additional markets outside the US and EU

Click here ­to­ read full press release/ article | Ref: BMS| Image: StraitTimes