Shots:

• 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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Ref: BMS | Image: BMS