* First new treatment option in more than 20 years to show a clinically meaningful improvement in progression-free survival is approved for people with previously untreated diffuse large B-cell lymphoma (DLBCL)
* Approval is based on pivotal data from the phase III POLARIX study, where Polivy plus R-CHP significantly improved progression-free survival with comparable safety versus the standard of care, R-CHOP
* First-line treatment with Polivy plus R-CHP has the potential to reduce the burden on patients and healthcare systems, associated with disease progression¹
DLBCL is an aggressive blood cancer and the most common form of non-Hodgkin lymphoma.² Each year in
"After more than 20 years with very limited treatment advances, the approval of Polivy plus R-CHP marks a new era for people battling this aggressive disease," said
"The approval of Polivy plus R-CHP in the first-line setting is great news for people in the
Today's EC approval was based on results from the phase III POLARIX study (GO39942), the first trial to show a clinically meaningful improvement in progression free survival (PFS), compared to standard of care rituximab plus cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP), in people with previously untreated DLBCL. All patients were followed for at least 24 months and at a median follow-up of 28.2 months, results of the study showed a 27% reduction in the risk of disease worsening or death with Polivy plus R-CHP compared to R-CHOP in first-line DLBCL (hazard ratio [HR] 0.73; 95% confidence interval [CI]: 0.57-0.95; P
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