EMA recommends EU approval of polatuzumab vedotin combination for untreated diffuse large B-cell lymphoma

On March 25, 2022, it was announced that the European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of polatuzumab vedotin in combination with rituximab plus cyclophosphamide, doxorubicin, and prednisone (R-CHP) for the first-line treatment of patients with diffuse large B-cell lymphoma (DLBCL). This recommendation is based on pivotal data from the ongoing phase III POLARIX study.^1,2

DLBCL is the most commonly diagnosed form of non-Hodgkin lymphoma, with an estimated 40,000 patients diagnosed each year.³ The current standard of care for DLBCL is the combination therapy R-CHOP, which consists of rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisolone. R-CHOP fails approximately 40% of patients and it is hoped that approval of the polatuzumab vedotin combination will bring an effective alternative treatment option to patients with previously untreated DLBCL.

The European Commission (EC) is expected to make a final decision regarding the approval in the near future.