Roche lymphoma treatment granted priority status by FDA

Roche announced on Tuesday that the US Food and Drug Administration (FDA) has accepted its 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 diffuse large B-cell lymphoma.

The Swiss pharmaceutical giant said the FDA was expected to make a decision on approval by 19 August.

“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 Roche’s chief medical officer and head of global product development Sandra Horning.

“We are working with the FDA to bring this important new option to patients with this aggressive disease as quickly as possible.”

Roche said the Biologics License Application was based on results of the GO29365 study, which showed that polatuzumab vedotin plus BR improved median overall survival compared to BR alone in people with relapsed or refractory diffuse large B-cell lymphoma, not eligible for a haematopoietic stem cell transplant.

The study also showed that 40% of people treated with polatuzumab vedotin plus BR achieved a complete response, while only 18% of people treated with BR alone achieved a complete response.

A complete response meant no cancer could be detected at that time.

Priority Review designation is granted to medicines that the FDA considered to have the potential to provide “significant improvements” in the safety and effectiveness of the treatment, prevention or diagnosis of a serious disease.

Polatuzumab vedotin was also granted ‘Breakthrough Therapy Designation’ by the FDA and ‘Priority Medicines’ (PRIME) designation by the European Medicines Agency for the treatment of people with relapsed or refractory diffuse large B-cell lymphoma in 2017.

Breakthrough Therapy Designation is designed to expedite the development and review of medicines intended to treat a serious condition, with preliminary evidence that indicated they could demonstrate substantial improvement over existing therapies.