Tag Archives: bb2121

BMS and bluebird bio Receive Priority Review for Ide-cel; PDUFA Projected Around March 27, 2021

On Tuesday, September 22, BMS and bluebird bio announced (press release, BMS / press release, bluebird bio) that the FDA has granted a Priority Review for ide-cel (BCMA CAR-T) in ≥4L RRMM with a projected PDUFA date around March 27, 2021. Below, Celltelligence provides additional thoughts on Ide-cel’s anticipated approval and the potential impact on BMS’s CVR milestone if the FDA requests additional information.

This content is for Read Less members only.
Register
Already a member? Log in here

bluebird bio Highlights Ide-cel Resubmission; Q2 2020 Earnings Call

On Wednesday, August 5, bluebird bio released their Q2 2020 financial results (press release). No new data was reported; however, the company highlighted the successful resubmission of their ide-cel BLA application. Below, Celltelligence provides insights on ide-cel’s potential approval date in the EU and a possible alternative messaging strategy for the CAR-T in earlier lines of therapy.

This content is for Read Less members only.
Register
Already a member? Log in here

BMS and bluebird bio Resubmit Ide-cel to FDA; Dynamic H1 2021 BCMA Launch Environment Expected with Janssen

On Wednesday, July 29, BMS and bluebird bio announced (press release) the resubmission of their BLA application for ide-cel (bb2121) to the FDA. According to the press release, the submission provides further details on the CMC module, addressing the additional regulatory information requested by the FDA in May 2020 (see previous insight). Below, Celltelligence provides additional thoughts on ide-cel’s potential approval, and the possible benefit a delayed ide-cel launch could have for Janssen.

This content is for Read Less members only.
Register
Already a member? Log in here