FDA Grants Priority Review to Polatuzumab Vedotin Combination for R/R DLBC

The FDA granted a priority review to polatuzumab vedotin in combination with bendamustine plus rituximab (Rituxan; BR) for the treatment of patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), according to Genentech, the anti-CD79b antibody drug conjugate’s manufacturer.

The biologic license application was based on results from the global, randomized phase Ib/II GO29365 study, designed to evaluate the safety, tolerability and activity of polatuzumab vedotin in combination with BR or obinutuzumab (Gazyva) in R/R follicular lymphoma or DLBCL. The primary endpoint was complete response (CR) at the end of treatment, while secondary endpoints included objective response (ORR) by investigator assessment and best objective response at the end of treatment by investigator and independent review committee assessment. Exploratory endpoints included duration of response (DOR), progression-free survival (PFS), event-free survival (EFS), and overall survival (OS).

“Polatuzumab vedotin, a potential first-in-class antibody drug conjugate, in combination with bendamustine and Rituxan, improved clinical outcomes including survival in some people with relapsed or refractory diffuse large B-cell lymphoma compared to bendamustine and Rituxan alone,” Sandra Horning, M.D., chief medical officer and head of global product development, said in a