Janssen Reports MAA Submission to EMA for Cilta-cel to Treat Relapsed/ Refractory Multiple Myeloma

April 30, 2021 Auto Bot EMA, Janssen, MAA, multiple myeloma, Refractory, regulatory, Relapsed, Submission 0

Shots:

  • The application is based on P-Ib/II CARTITUDE-1 study evaluating cilta-cel in adults with r/r MM who have received at least prior 3L therapies across the US, EU, China, and Japan
  • The 1EP of the P-Ib study is to characterize the safety and confirm the dose of the therapy while the primary objective of P-II study is evaluating the efficacy of JNJ-4528 with 1EPs as ORR
  • The MAA follows the confirmation of accelerated assessment from EMA’s CMPH while the BLA for the therapy is under US FDA’s review

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