Shots:
- The EMA has received the Type II variation application for Tecvayli monotx. (teclistamab) for the treatment of adults with r/r multiple myeloma (RRMM) who have received ≥1 prior therapy
- Application was supported by the P-III (MajesTEC-9) trial assessing Tecvayli vs SoC of pomalidomide, bortezomib, & dexamethasone (PVd) or carfilzomib & dexamethasone (Kd) in 614 pts with RRMM
- Trial showed superior PFS & OS as early as 2L of treatment, reducing the risk of progression or death by 71% & death risk by 40% in pts that were predominantly refractory to anti-CD38 mAb & lenalidomide; the IDMC recommended study unblinding after the first interim analysis
Ref: Globenewswire | Image: J&J | Press Release
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