Roche to get quicker review of its anti cancer Rituxan combination, in August

Roche on Tuesday got nod from the US Food and Drug Administration (FDA) that it’s anti-cancer combination might have the potential to provide significant improvements in the safety and effectiveness of the treatment, prevention or diagnosis of a serious disease.

Roche expects the FDA’s decision on approval by August 19, 2019, for its polatuzumab vedotin in with bendamustine plus Rituxan (rituximab) (BR) for the treatment of people with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL).

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

The Biologics License Application is based on results of the GO29365 study, Roche said in the press release, which showed that polatuzumab vedotin plus BR improved median overall survival compared to BR alone, in people with R/R DLBCL not eligible for a haematopoietic stem cell transplant.

In addition, the study showed that 40% of people treated with polatuzumab vedotin plus BR achieved a complete response (CR), while only 18% of people treated with BR alone achieved a CR. A CR means no cancer could be detected at that time.