FDA accepts BLA for polatuzumab vedotin + bendamustine + Rituxan for the treatment relapsed or refractory diffuse large B-cell lymphoma (DLBCL). Genentech/Roche

Genentech has announced that the FDA has accepted the company�s Biologics License Application (BLA) and granted Priority Review for polatuzumab vedotin in combination with bendamustine plus Rituxan (rituximab) (BR) for the treatment of people with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL). The FDA is expected to make a decision on approval by 19 August 2019.

The BLA is based on results of the GO29365 study, which showed that polatuzumab vedotin plus BR improved median overall survival compared to BR alone (12.4 vs. 4.7 months, HR=0.42; 95 percent CI 0.24-0.75; exploratory endpoint), in people with R/R DLBCL not eligible for a hematopoietic stem cell transplant. The study also showed that 40 percent of people treated with polatuzumab vedotin plus BR achieved a complete response (CR), while only 18 percent of people treated with BR alone achieved a CR (primary endpoint, as measured by positron emission tomography; CR rates assessed by independent review committee). A CR means no cancer could be detected at that time.