Posted by Michael Wonder on 29 Jul 2020
Bristol Myers Squibb and bluebird bio announce submission of biologics license application to FDA for idecabtagene vicleucel (Ide-cel, bb2121) for adults with relapsed and refractory multiple myeloma
29 July 2020 - BLA submission based on results from pivotal Phase 2 KarMMa study evaluating ide-cel in heavily pre-treated patient population.
Bristol Myers Squibb and bluebird bio today announced the submission of their biologics license application to the U.S. FDA for idecabtagene vicleucel (ide-cel; bb2121), the companies’ investigational B-cell maturation antigen-directed chimeric antigen receptoe T cell immunotherapy, for the treatment of adult patients with relapsed and refractory multiple myeloma.
This submission provides further details on the Chemistry, Manufacturing and Controls module to address the outstanding regulatory requests from the FDA in May 2020 following the original submission from March 2020.
