US regulators have refused to file Bristol Myers Squibb and bluebird bio's marketing application seeking approval of idecabtagene vicleucel (ide-cel) for patients with heavily pre-treated relapsed and refractory multiple myeloma.
Upon preliminary review, the US Food and Drug Administration has determined that the Chemistry, Manufacturing and Control (CMC) module of the application needs further detail to complete the review.
On the plus side, the regulator did not request additional clinical or non-clinical data.
A such, BMS said it is planning to resubmit the application no later than the end of July 2020.
Ide-cel is a B-cell maturation antigen (BCMA)-directed genetically modified autologous chimeric antigen receptor (CAR) T cell immunotherapy.
In addition to the pivotal KarMMa trial evaluating ide-cel in patients with relapsed and refractory multiple myeloma, the companies are assessing the therapy's potential in earlier lines of treatment.