EU Approves Roche's Polivy Combination For Previously Untreated Diffuse Large B-cell Lymphoma

Roche (RHHBY) said that the European Commission has granted approval of Polivy or polatuzumab vedotin in combination with MabThera or rituximab plus cyclophosphamide, doxorubicin, and prednisone for the treatment of adult patients with previously untreated diffuse large B-cell lymphoma or DLBCL.

DLBCL is an aggressive blood cancer and the most common form of non-Hodgkin lymphoma.

The 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, compared to standard of care rituximab plus cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP), in people with previously untreated DLBCL.

The European Commission also converted Polivy's initial conditional marketing authorisation in the European Union for the treatment of adult patients with relapsed or refractory DLBCL, who are not candidates for a haematopoietic stem cell transplant, to a full approval.

Roche continues to explore areas where Polivy has the potential to deliver additional benefit, including ongoing studies investigating combinations of Polivy with CD20xCD3 T-cell engaging bispecific antibodies in previously treated/untreated DLBCL.

Polivy is a first-in-class anti-CD79b antibody-drug conjugate (ADC). The CD79b protein is expressed specifically in the majority of B-cells, an immune cell impacted in some types of non-Hodgkin lymphoma (NHL), making it a promising target for the development of new therapies.Polivy binds to cancer cells such as CD79b and destroys these B-cells through the delivery of an anti-cancer agent, which is thought to minimise the effects on normal cells.

Polivy is being developed by Roche using Seagen ADC technology and is currently being investigated for the treatment of several types of NHL. Polivy is currently marketed in the EU for the treatment of relapsed or refractory diffuse large B-cell lymphoma.

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