US FDA approved Roche’s Polivy in combination with R-CHP for DLBCL

CAR-T Digest - August 2020

April 19, 2023: Polatuzumab vedotin-piiq (IV) / DLBCL / Roche: Received US FDA approval

Roche announced US FDA approval of Polivy® (polatuzumab vedotin-piiq) in combination with Rituxan® (rituximab), cyclophosphamide, doxorubicin and prednisone (R-CHP) for the treatment of untreated DLBCL
Approval was based on POLARIX study that reduced the risk of disease progression, relapse, or death by 27% compared to the standard of care, R-CHOP, with a comparable safety profile
Polivy combination is the first FDA-approved therapy in nearly 20 years for the first-line treatment of DLBCL
It has already approved in more than 70 countries for the treatment of previously untreated DLBCL, including in the EU, UK, Japan, Canada, and China