The sBLA was based on the P-III (POLARIX) trial that evaluates Polivy + R-CHP vs R-CHOP in 879 patients in a ratio (1:1) with DLBCL. The US FDA’s decision on approval is expected on April 2, 2023
The results showed an improvement in PFS, 27% reduction in risk of disease progression, relapse, or death after a median follow-up of 28.2mos. The safety outcomes were consistent with prior trials, grade 3-4 AEs (57.7% vs 57.5%), SAEs (34.0% vs 30.6%), grade 5 AEs (3.0% vs 2.3%), and AEs leading to dose reduction (9.2% vs 13.0%)
The therapy is currently approved as a readily available, fixed-duration treatment option for r/r DLBCL in combination with bendamustine and Rituxan/Mabthera in 70+ countries globally incl in the US & EU
Ref: GlobeNewswire | Image: Genentech
