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GSK’s Blenrep (Belantamab Mafodotin) Regimen Receives the US FDA’s Approval to Treat R/R Multiple Myeloma

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  • The US FDA has approved Blenrep + BorDex for the treatment of r/r MM in adults who have received ≥1 prior therapy, incl. a proteasome inhibitor & an immunomodulatory agent. NDA under NMPA’s priority review
  • Approval was based on P-III (DREAMM-7) trial assessing Blenrep (2.5mg/kg, IV, Q3W) in combination with BorDex for 8 cycles, then as a single agent vs Darzalex + BorDex in 494 pts with r/r MM
  • DREAMM-7 showed a 51% reduction in death risk (mPFS: 31.3 vs 10.4mos.) in 3L+ pts; follow-up OS data from DREAMM-7 & 8, as well as data from P-III (DREAMM-10) trial in newly diagnosed, transplant-ineligible pts are expected in early 2028, with US site expansion for DREAMM-10

Ref: GSK | Image: GSK | Press Release

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