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Shots:
- CHMP recommended Blenrep + BorDex & PomDex in MM pts with ≥1 prior therapy; EC decision expected in Q3’25. Review ongoing in the US (PDUFA: Jul 23, 2025), Canada, China (PR for DREAMM-7), & Switzerland (PR for DREAMM-8)
- Opinion was based on P-III (DREAMM-7 & DREAMM-8) trials assessing Blenrep + BorDex vs Darzalex + BorDex in 494 pts & Blenrep + PomDex (BPd) vs Velcade + PomDex in 302 pts, respectively
- DREAMM-7 showed improved PFS (1EP; mPFS: 36.6 vs 13.4mos.), depicting a 42% reduced death risk at 39.4 mFU & 3yr. OS rate (2EP) of 74% vs 60%, while DREAMM-8 showed unreached mPFS vs 12.7mos. at 21.8mos. mFU, 71% vs 51% pts alive with no progression at yr. end, favorable OS trend under review, & consistent BPd benefit across all subgroups
Ref: GSK| Image: GSK| Press Release
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