Roche Receives FDA Approval for Polivy in Frontline Diffuse Large B-Cell Lymphoma

Roche today announced that the FDA has approved Polivy (polatuzumab vedotin-piiq) in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CHP) for the treatment of previously untreated diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma. In the Phase 3 POLARIX trial, Polivy plus R-CHP demonstrated a statistically significant improvement in progression-free survival compared to R-CHOP. The 2-year PFS rate was 76.7% for Polivy plus R-CHP versus 70.2% for R-CHOP. This approval establishes Polivy plus R-CHP as a new standard of care in frontline DLBCL treatment.