Roche’s polatuzumab vedotin gets Priority Review from FDA

Roche has announced that the FDA has approved its Biologics License Application and granted Priority Review for polatuzumab vedotin in combination with bendamustine and Rituxan for the treatment of people with relapsed or refractory diffuse large B-cell lymphoma. The BLA is based on results of the GO29365 study which demonstrated that polatuzumab vedotin in combination with bendamustine and Rituxan improved median overall survival (12.4 months) versus bendamustine and Rituxan alone (4.7 months) in people with R/R DLBCL not eligible for a haematopoietic stem cell transplant. The study also showed that 40% of people treated with polatuzumab vedotin in combination with bendamustine and Rituxan achieved a complete response, i.e. no cancer could be detected at that time, while only 18% of people treated with bendamustine and Rituxan alone achieved a complete response.

Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development, said: “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. We are working with the FDA to bring this important new option to patients with this aggressive disease as quickly as possible.”