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

  Ref: Businesswire | Image: Janssen