Genentech Medicine Received Accelerated FDA Approval as a New Treatment Option for People with Previously Treated Aggressive Lymphoma
June 10th, 2019
On June 10, 2019, the FDA granted accelerated approval to Polivy™ (polatuzumab vedotin-piiq) in combination with bendamustine plus Rituxan® (rituximab) (BR) for the treatment of adults with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), who have received at least two prior therapies. Accelerated approval was granted for this indication based on complete response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. The FDA's Accelerated Approval Program allows conditional approval of a medicine that fills an unmet medical need for a serious condition.
News in brief
- This accelerated approval is based on the Phase Ib/II GO29365 study, which showed Polivy in combination with BR resulted in higher complete response rates for people with R/R DLBCL compared to BR alone.
- Polivy is a first-in-class anti-CD79b antibody-drug conjugate. The CD79b protein is expressed in the majority of B-cells, an immune cell impacted in some types of non-Hodgkin’s lymphoma (NHL), making it a promising target for the development of new therapies.
- DLBCL is the most common form of NHL, accounting for about one in three cases. In the U.S., it is estimated that nearly 25,000 new cases of DLBCL will be diagnosed in 2019.
Supporting Information
“Despite meaningful progress in the treatment of diffuse large B-cell lymphoma, treatment options are very limited when the disease is refractory to or recurrent after multiple regimens,” said Sandra Horning M.D., chief medical officer and head of Global Product Development. “Today’s approval of this Polivy combination will provide a novel treatment that is both immediately available and very much needed for people with this aggressive disease.”