FDA, EMA put a star CAR-T from bluebird and Celgene on the VIP list
During the last ASCO bluebird bio and its partners at Celgene angled into center stage with an update on their BCMA-targeting CAR-T drug bb2121 for multiple myeloma that wowed the cancer crowd.
The FDA as well as European regulators were paying attention. Today the two companies announced that both groups had put the program on their VIP list, with a breakthrough therapy designation right alongside PRIME status.
Here’s what they were responding to from ASCO:
With 18 patients evaluable for efficacy, there were 15 in what bluebird termed active dosing regimens above the minimum for bb2121, and all of them achieved an objective response. Twelve achieved a very good partial response to complete response, associated with longer survival times. And of the 4 patients evaluable for minimal residual disease status, all were MRD negative with only a few or no myeloma cells in circulation.
That is outstanding, and these days it’s the kind of therapy that gets pushed along by regulators anxious to see these new standards of care expand on the market as fast as possible. It’s also a big help for these companies as they look to shine a light on this therapy at the upcoming ASH conference, which you can read more about here.
David Davidson, the CMO for bluebird bio, had this to say:
Early data suggest that treatment with bb2121 has the potential to induce durable responses in this patient population. It is encouraging for both the FDA and EMA to identify bb2121 as a candidate for accelerated development as we continue our work with Celgene to bring this therapy to patients in need of new options.