Genentech’s Polivy (polatuzumab vedotin) Receives the US FDA’s Approval for Diffuse Large B-cell Lymphoma
Shots:
- The US FDA has approved Polivy in combination with Rituxan, cyclophosphamide, doxorubicin & prednisone (R-CHP) for adult patients before untreated DLBCL
- The approval was based on the P-III trial (POLARIX) evaluating Polivy + R-CHP vs R-CHP in a ratio (1:1) in 1000 patients. The trial is being conducted in collaboration with LYSA & LYSARC
- The results showed an improvement in PFS, a 27% reduction in risk of disease progression, relapse, or death. The safety profile was comparable, rates of grade 3-4 AEs (57.7% vs 57.5%), serious AEs (34.0% vs 30.6%), grade 5 AEs (3.0% vs 2.3%) & AEs leading to dose reduction (9.2% vs 13.0%). Polivy + bendamustine & Rituxan are currently approved in 80+ countries globally for r/r DLBCL
Ref: Businesswire | Image: Genentech
Related News:- Genentech Reports the US FDA Acceptance of sBLA for Polivy (polatuzumab vedotin-piiq) to Treat Diffuse Large B-Cell Lymphoma
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