Bristol Myers Says EMA Validates Applications for Idecabtagene Vicleucel, CC-486
May 22 2020 - 8:25AM
Dow Jones News
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
(END) Dow Jones Newswires
May 22, 2020 08:10 ET (12:10 GMT)
Copyright (c) 2020 Dow Jones & Company, Inc.
bluebird bio (NASDAQ:BLUE)
Historical Stock Chart
From Mar 2024 to Apr 2024
bluebird bio (NASDAQ:BLUE)
Historical Stock Chart
From Apr 2023 to Apr 2024
