Roche’s Columvi (Glofitamab) Regimen Receives the EC’s Approval to Treat R/R Diffuse Large B-Cell Lymphoma (DLBCL)
Shots:
- The EC has granted full approval to Columvi + GemOx for ASCT-ineligible r/r DLBCL pts based on P-III (STARGLO) trial assessing the regimen vs MabThera/Rituxan + GemOx in previously treated DLBCL pts
- At 11.3mos. mFU (primary analysis), trial showed improved OS, a 41% reduction in death risk, with a 63% improvement in PFS. At 20.7mos. mFU (follow-up analyses), mOS was 25.5 vs 12.9mos. & CRs were seen in 58.5% vs 25.3% pts
- Columvi is also being evaluated in P-III (SKYGLO) trial in combination with Polivy + MabThera/Rituxan, cyclophosphamide, doxorubicin & prednisone (Pola-R-CHP) vs Pola-R-CHP in previously untreated DLBCL pts
Ref: Globenewswire | Image: Roche
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