GSK Reports the US FDA’s BLA Acceptance of Blenrep (Belantamab Mafodotin) Regimen for Treating R/R Multiple Myeloma
Shots:
- The US FDA has accepted the BLA of Blenrep plus BorDex & PomDex in MM patients with at least 1 prior therapy (PDUFA: Jul 23, 2025). Reviews are underway in the EU, UK, Japan (priority review), Canada, Switzerland (priority review for DREAMM-8) & China (priority review for DREAMM-7)
- BLA was based on P-III (DREAMM-7 & DREAMM-8) studies assessing Blenrep + BorDex vs daratumumab + BorDex and Blenrep + PomDex vs bortezomib + PomDex, respectively for treating r/r MM
- Both the studies depicted improvements in 2EPs of deeper & durable responses; DREAMM-7 showed a significant OS benefit, while DREAMM-8 showed a positive OS trend that was insignificant & its follow-up is underway. Full data will be highlighted at ASH 2024
Ref: GSK | Image: GSK
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
