Shots:

• The MAA submission is based on a P-Ib/II CARTITUDE-1 study assessing the safety and efficacy of cilta-cel in adults with r/r MM. The company is expected to submit MAA to EMA in H1’21
• The accelerated approval milestone in EU follows the rolling submission for cilta-cel to the US FDA in Dec’2020
• Cilta-cel is an investigational BCMA-directed CAR-T therapy in development for the treatment of adults with r/r MM. CHMP’s accelerated assessment can reduce the review timelines to evaluate an MAA

 ­ Ref: Businesswire | Image:Janssen