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FDA Grants Priority Review To Roche's Polatuzumab Vedotin On Lymphoma

Roche (RHHBY) said that the US Food and Drug Administration has accepted the company's Biologics License Application or BLA and granted Priority Review for polatuzumab vedotin in combination with bendamustine plus Rituxan or rituximab or BR for the treatment of people with relapsed or refractory (R/R) diffuse large B-cell lymphoma or 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% CI 0.24-0.75; exploratory endpoint), 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 plus BR achieved a complete response (CR), while only 18% 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.

Priority Review designation is granted to medicines that the FDA considers 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 PRIME (PRIority MEdicines) designation by the European Medicines Agency for the treatment of people with R/R DLBCL in 2017.

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