The European Commission has approved Roche’s Polivy (polatuzumab vedotin) for people with previously treated aggressive lymphoma.
The Commission’s marketing authorisation is for the drug in combination with bendamustine plus MabThera (rituximab), for the treatment of adult patients who have relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) and are not candidates for a haematopoietic stem cell transplant.
On the news of the approval, “people in the EU with relapsed or refractory diffuse large B-cell lymphoma will have the opportunity to benefit from this new Polivy combination,” said Levi Garraway, Roche’s chief medical officer and head of global product development.
He reminded, “For patients battling this aggressive disease, the prognosis is poor and few treatments are available. We are proud to bring this first-in-class treatment option to those who need it most.”
Roche revealed that the conditional approval is based on the results from the phase Ib/II GO29365 study, the first and only clinical trial to show higher response rates and improved overall survival (OS) compared to MabThera in the indication.
Data revealed that 40% of people treated with Polivy plus MabThera achieved a complete response, and as such no cancer could be detected at the time of assessment, compared to 17.5 with just MabThera alone.
Roche reminds that the EU approval follows the US Food and Drug Administration’s (FDA) accelerated approval of the combo in June last year.
DLBCL is the most common form of non-Hodgkin lymphoma (NHL), accounting for about one in three cases.