Roche Announces U.S. FDA Approval of Polivy in Combination with R-CHP

Wednesday, April 19, 2023

Roche announced that the U.S. Food and Drug Administration (FDA) has approved Polivy® (polatuzumab vedotin-piiq) in combination with Rituxan® (rituximab), cyclophosphamide, doxorubicin and prednisone (R-CHP) for the treatment of adult patients with certain types of previously untreated diffuse large B-cell lymphoma.

• Polivy combination is the first FDA-approved therapy in nearly 20 years for the first-line treatment of diffuse large B-cell lymphoma, an aggressive disease and the most common form of non-Hodgkin lymphoma in the US
• POLARIX trial showed the Polivy combination reduced the risk of disease progression, relapse or death by 27% compared to the standard of care, R-CHOP, with a comparable safety profile
• First-line treatment with Polivy plus R-CHP has the potential to reduce the burden on patients and healthcare systems, associated with disease progression

The FDA approval of Polivy in combination with R-CHP brings a much-needed new treatment option which improves outcomes and bring other benefits to many patients with this aggressive lymphoma.

More than 70 countries have approved this Polivy combination for the treatment of adult patients with previously untreated DLBCL, including in the EU, UK, Japan, Canada and China.