Please login to the form below

Not currently logged in

Roche’s Polivy receives EC approval for lymphoma therapy

The combination therapy is for patients with previously untreated diffuse large B-cell lymphoma


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.

Article by
John Pinching

26th May 2022

From: Research, Regulatory, Healthcare



Subscribe to our email news alerts

Featured jobs


Add my company
Branding Science

We are Branding Science Partners in thinking which inspires change in healthcare Branding Science are an award-winning global pharmaceutical market...

Latest intelligence

Virtual MSL/Sales training programs and events
Top 10 ways to leverage the Impetus InSite Platform® for internal MSL/Sales training programs and events...
6 trends shaping the future of personalized medicine
Senior Consultant Leah Carlisle explores the key trends discussed at the 16th annual Personalized Medicine Conference, providing expert analysis and key recommendations for biopharmaceutical innovators....
Omnichannel strategies to revolutionize the healthcare professional experience
Fishawack Health’s omnichannel experts unite to reveal how medical and commercial teams can build more meaningful experiences for healthcare professionals. They discuss the opportunities of omnichannel and explore how the...