Source: globenewswire.com
The U.S. Food and Drug Administration has accepted Roche’s Biologics License Application and granted Priority Review for polatuzumab vedotin in combination with bendamustine plus Rituxan (BR) for the treatment of people with relapsed or refractory (R/R) diffuse large B-cell lymphoma. The Biologics License Application is based on the 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 expected decision for approval is anticipated by 19 August 2019.
