Shots:
- MHLW has approved Blenrep + BorDex & PomDex in MM pts with ≥1 prior therapy; review ongoing in the US (PDUFA: Jul 23, 2025), EU, Canada, China (PR for DREAMM-7), & Switzerland (with PR for DREAMM-8)
- Approval was based on P-III (DREAMM-7 & DREAMM-8) trials assessing Blenrep (2.5mg/kg, IV, Q3W) + BorDex vs Darzalex + BorDex in 494 pts & Blenrep + PomDex (BPd) vs Velcade + PomDex in 302 pts, respectively
- DREAMM-7 met its 1EP of improved PFS (mPFS: 36.6 vs 13.4mos.) & 2EP of OS, showing a 42% reduced death risk at 39.4 mFU & 3yr. OS rate of 74% vs 60%, while DREAMM-8 (21.8mos. mFU) showed unreached mPFS vs 12.7mos., 71% vs 51% pts alive with no progression at year end, a favorable OS trend under review, & consistent BPd benefit across all subgroups
Ref: GSK | Image: GSK| Press Release
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