BMS Reviews 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

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  • The MAA of ide-cel is in line with P-II KarMMa learn about assessing ide-cel in closely pre-treated 140 sufferers with r/r MM, prior handled with a minimum of three remedies together with an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody
  • The MAA of CC-486 is in line with P-III QUAZAR AML-001 learn about assessing CC-486 (300mg) vs PBO in 472 sufferers in a ratio (1:1) with AML, who CR/ CRi, following induction treatment with/out consolidation remedy, and who don’t seem to be applicants for hematopoietic stem cellular transplantation
  • Ide-cel is BCMA directed genetically changed autologous CART cellular immunotherapy, co-developed via BMS and bluebird, and has won EMA’s Speeded up Evaluation standing in Mar 26, 2020, decreasing the utmost time frame for assessment of the applying to 150 days. CC-486 is an oral hypomethylating agent that accommodates into DNA and RNA

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Comparable Information: BMS and bluebird bio to Resubmit the BLA for Idecabtagene Vicleucel (ide-cel, bb2121) to Deal with Sufferers with A couple of Myeloma



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