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

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

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

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 3 prior line 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 the 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 CHMP while the BLA for the therapy is under US FDA’s review

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

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