FDA Approves Roche's Polivy Combo Therapy For Untreated Patients With Diffuse Large B-Cell Lymphoma

The FDA has approved Roche Group AG's RHHBY Genentech's Polivy (polatuzumab vedotin-piiq) in combination with Rituxan (rituximab), cyclophosphamide, doxorubicin and prednisone (R-CHP) for previously untreated diffuse large B-cell lymphoma (DLBCL).
The approval covers DLBCL patients not otherwise specified (NOS) or high-grade B-cell lymphoma (HGBL) and who have an International Prognostic Index (IPI) score of two or greater.
Polivy combination is the first FDA-approved therapy in nearly 20 years for the first-line treatment of diffuse large B-cell lymphoma, the most common form of non-Hodgkin's lymphoma in the U.S.
This FDA decision converts the accelerated approval of Polivy in combination with bendamustine and Rituxan for relapsed or refractory (R/R) DLBCL after at least two prior therapies to regular approval.
The FDA approval is based on data from POLARIX Phase 3 trial that demonstrated a statistically significant and clinically meaningful improvement in PFS compared to R-CHOP.
The risk of disease progression, relapse, or death was reduced by 27% with Polivy plus R-CHP.
This approval follows the FDA Oncologic Drugs Advisory Committee (ODAC) vote of 11 to 2 in favor of Polivy in combination with R-CHP for previously untreated DLBCL.