FDA grants priority review to Roche’s polatuzumab vedotin in previously treated aggressive lymphoma

Roche

19 February 2019 - Polatuzumab vedotin has shown significant potential to improve outcomes in people living with this disease.

Roche today announced that the U.S. 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% CI 0.24-0.75; exploratory endpoint), in people with R/R DLBCL not eligible for a haematopoietic stem cell transplant.

Read Roche press release

Michael Wonder

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Michael Wonder

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Cancer , Medicine , US , Priority review