BMS Reports EMA’s Validation of MAA for Idecabtagene Vicleucel (Ide-cel, bb2121) and CC-486

BMS Reports Results of Triple Regimen in P-III ELOQUENT-1 Study for Patients with Newly Diagnosed Untreated Multiple Myeloma


  • The MAA of ide-cel is based on P-II KarMMa study assessing ide-cel in heavily pre-treated 140 patients with r/r MM, prior treated with at least 3 therapies including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody
  • The MAA of CC-486 is based on P-III QUAZAR AML-001 study assessing CC-486 (300mg) vs PBO in 472 patients in a ratio (1:1) with AML, who CR/ CRi, following induction therapy with/out consolidation treatment, and who are not candidates for hematopoietic stem cell transplantation
  • Ide-cel is BCMA directed genetically modified autologous CART cell immunotherapy, co-developed by BMS and bluebird, and has received EMA’s Accelerated Assessment status in Mar 26, 2020, reducing the maximum timeframe for review of the application to 150 days. CC-486 is an oral hypomethylating agent that incorporates into DNA and RNA

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Related News: BMS and bluebird bio to Resubmit the BLA for Idecabtagene Vicleucel (ide-cel, bb2121) to Treat Patients with Multiple Myeloma