CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
August 2019—Genentech announced that the FDA has granted accelerated approval to Polivy (polatuzumab vedotin-piiq) in combination with bendamustine plus Rituxan (rituximab) for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma who have received at least two prior therapies. Accelerated approval was granted based on complete response rates observed in the phase one-b/two GO29365 study, a randomized, controlled clinical trial.
This is the first randomized pivotal clinical trial to show higher response rates over bendamustine plus rituximab (BR) in people with R/R DLBCL who are ineligible for a hematopoietic stem cell transplant, the company reports. Results of the study showed that 40 percent of people treated with Polivy plus BR achieved a complete response (n =16/40; 95 percent CI, 25–57) compared with 18 percent with BR alone (n =7/40; 95 percent CI, 7–33).