Following a wait of 20 years for a clinically meaningful improvement for patients with untreated diffuse large B-cell lymphoma (DLBCL), the European Commission (EC) has granted approval of Roche’s Polivy (polatuzumab vedotin) in combination with MabThera.
The complex treatment also incorporates cyclophosphamide, doxorubicin and prednisone (R-CHP).
Every year in Europe approximately 40,000 people are diagnosed with DLBCL, a very aggressive form of blood cancer. While many patients are initially responsive to treatment, four out of ten are not cured with the existing standard of care.
Approval was based on results from the POLARIX study – a phase 3 trial that demonstrated a significant improvement in progression-free survival, compared to the standard care provided.
The study involved those with previously untreated DLBCL and all patients were followed for at least two years. Results demonstrated that, following the therapy, there was a 27% reduction in the risk of the disease worsening or death.
The study continues to be conducted in collaboration with The Lymphoma Study Association and The Lymphoma Academic Research Organisation.
“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 Levi Garraway, Roche’s chief medical officer and head of global product development.
“We are delighted that the European Commission has approved this Polivy regimen and believe it has the potential to make a significant impact on the lives of people with DLBCL.”
Professor Hervé Tilly, POLARIX principal investigator and Professor of Haematology at the University of Rouen, said: “The approval of Polivy plus R-CHP in the first-line setting is great news for people in the EU diagnosed with this aggressive lymphoma, giving them a greater opportunity for positive outcomes.”
“Treatment with this regimen has been shown to reduce the chance of relapse and therefore need for subsequent treatments, limiting the burden of DLBCL.”
In the EU, Polivy’s initial conditional marketing authorisation has been given full approval by the European Commission.