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

 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

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

Click here ­to­ read full press release/ article | Ref: BMS | Image: BMS

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

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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