GSK Reports the NDA Acceptance of Blenrep Combinations by the Japanese MHLW for R/R Multiple Myeloma
Shots:
- The Japanese MHLW has accepted the NDA of Blenrep in addition to bortezomib & dexamethasone (BorDex) or pomalidomide & dexamethasone (PomDex) for treating r/r multiple myeloma
- The application 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 reached the 1EP, showing significantly improved PFS and an OS trend that was not significant during the analysis, though the follow-up is underway. Improvements were also observed in the 2EPs; safety aligned with the known profiles
Ref: GSK | Image: GSK
Related News:- GSK’s Blenrep Combination Gains the NMPA’s Breakthrough Therapy Designation to Treat R/R Multiple Myeloma
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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.
