US FDA’s Accepts sBLA of Roche's Columvi (Glofitamab) Combination to Treat R/R Diffuse Large B-Cell Lymphoma (DLBCL)
Shots:
- The US FDA has accepted sBLA of Columvi + GemOx for r/r DLBCL patients previously treated for at least 1st Line & ineligible for autologous stem cell transplant (PDUFA: Jul 20, 2025). Data has been submitted globally, incl. EMA for approval
- This sBLA was based on P-III (STARGLO) study of Columvi + GemOx vs MabThera/Rituxan + GemOx for r/r DLBCL, to convert accelerated & conditional approval to full approval in the US & EU, respectively
- Primary analysis (median follow-up: 11.3mos.) showed improved survival, reducing the death risk by 41% & mOS not reached vs 9mos. Safety aligned with the individual profiles; AEs rates were high with Columvi reflecting higher median treatment cycles (11 vs 4)
Ref: Roche | Image: Roche
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