By Michael Dabaie 



  Bristol Myers Squibb said the European Medicines Agency validated its marketing authorization applications for both idecabtagene vicleucel and CC-486. 


  Validation of each application confirms the respective submissions are complete and begins the EMA's centralized review process. 


  The marketing authorization application for ide-cel is for the treatment of adult patients with multiple myeloma who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody. 


  The MAA for CC-486 is for the maintenance treatment of adult patients with acute myeloid leukemia who achieved complete remission or complete remission with incomplete blood count recovery, following induction therapy with or without consolidation treatment, and who aren't candidates for, or who choose not to proceed to, hematopoietic stem cell transplantation. 


  The applications are based on positive results from pivotal KarMMa study in relapsed and refractory multiple myeloma and QUAZAR AML-001 study in acute myeloid leukemia, the company said. 


  Ide-cel is being developed as part of an agreement between Bristol Myers Squibb and bluebird bio Inc. 


  Write to Michael Dabaie at michael.dabaie@wsj.com