EC approval of polatuzumab vedotin in combination with bendamustine and rituximab for R/R DLBCL

On the 21^st January 2020, polatuzumab vedotin (pola) in combination with bendamustine and rituximab (BR), was granted conditional marketing authorization by the European Commission (EC), for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) ineligible for a hematopoietic stem cell transplant.¹

Pola is a first-in-class antibody-drug conjugate against CD79b, a protein expressed specifically by B cells.^2,3 Upon binding, the antibody delivers a cytotoxic dose of microtubule inhibitor, monomethyl auristatin E.

The approval follows the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommendation (read here) and was based on the positive results from a multicenter phase Ib/II GO29365 study (NCT02257567) evaluating the efficacy and safety of the combination in R/R DLBCL and FL.³ The results from 80 patients demonstrated superior response rates and overall survival in patients receiving pola-BR compared with BR alone. The interview with Laurie Sehn discussing the results is available here.

In 2019, we reported the accelerated approval for the same indication by the US Food & Drug Administration (FDA). Pola-BR has also received breakthrough therapy designation by the FDA and PRIME (PRIority MEdicines) designation by the EMA for the treatment of patients with R/R DLBCL.