Conditional nod for polatuzumab combo to treat lymphomaMarch 6, 2020
Polatuzumab vedotin has been granted conditional marketing authorisation by EC in combination with bendamustine plus rituximab (BR) for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL).
The conditional approval is based on the results from the phase Ib/II GO29365 study, the first and only clinical trial to show higher response rates and improved overall survival (OS) compared to BR, a commonly used regimen, in people with R/R DLBCL who are not candidates for a haematopoietic stem cell transplant.
The results of the study showed that 40% of people treated with polatuzumab plus BR achieved a complete response (n=16/40), meaning no cancer could be detected at the time of assessment, compared to 17.5% (n=7/40) with BR alone. Complete response rates were assessed by an independent review committee.
Polatuzumab vedotin is a first-in-class anti-CD79b antibody-drug conjugate (ADC).