Janssen Reports CHMP’s Acceptance for Accelerated Assessment of Cilta-cel’s MAA to Treat Patients with Heavily Pretreated Multiple Myeloma

February 2, 2021 Auto Bot CHMP, EMA, MAA, multiple myeloma, regulatory, reports, Submission, Treat 0

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

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

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