Biotech Bristol Myers, bluebird refile for CAR-T approval
11 August 2020
Bristol Myers Squibb and bluebird bio have refiled for approval of anti-BCMA CAR-T therapy ide-cel. The action, which comes two months after the FDA hit the partners with a refuse to file letter, keeps Bristol Myers in with a shot of winning approval before a deadline set in its takeover of Celgene.
Bristol Myers responded to the setback by vowing to resubmit the application “no later than the end of July 2020.” In the end, Bristol Myers met that target with a day or two to spare.
As a breakthrough therapy, ide-cel stands to benefit from a truncated six-month review. If everything goes smoothly from here on, Bristol Myers should hit the deadline established in the Celgene deal. Hitting the target would ensure ide-cel comes to market before Johnson & Johnson’s rival anti-BCMA CAR-T therapy, which is set to land on the FDA’s desk by the end of the year.
The stuttering progress of the other cell therapy covered by the Celgene agreement shows further twists are possible, though. Bristol Myers needs to win FDA approval for that asset, anti-CD19 CAR-T liso-cel, by the end of the year to meet the terms of the Celgene agreement. The Big Pharma is still on track to hit that goal, but two delays to the FDA decision date have reduced the wiggle room.
Published by Fiercebiotech on July 31, 2020
Image from Shutterstock