European Commission OKs Roche’s Polivy Combo for Large B-Cell Lymphoma

The European Commission has approved Roche’s Polivy (polatuzumab vedotin) in combination with MabThera (rituximab), cyclophosphamide, doxorubicin and prednisone, also known as R-CHP, for the first-line treatment of diffuse large B-cell lymphoma.

The commission’s decision is based on trial results showing clinically meaningful improvement on progression-free survival compared to the standard of care regimen rituximab plus cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP).

The approval follows the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP)’s favorable recommendation of the combo in March.

In addition, the European Commission gave full approval to Roche’s Polivy for adults with relapsed or refractory diffuse large B-cell lymphoma who are ineligible for hematopoietic stem cell transplant. Previously, the drug was under conditional marketing authorization for this specific indication.