• ipharmaservices

Genentech’s Polivy gets accelerated approval from the US FDA for patients with lymphoma

Genentech (a Roche’s company) has announced Polivy (polatuzumab vedotin-piiq) in combination with bendamustine and Rituxan (rituximab) has achieved accelerated approval from the US FDA. The combination was approved for the treatment of adult patients suffering from relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who received two prior therapies.


The antibody-drug conjugate acts by targeting CD79b, a protein expressed in the majority of B-cells.


The accelerated approval was based on Phase Ib/II GO29365 study. The primary endpoint was response rate. Combination of Polivy, bendamustine, and Rituxan has shown better response rates compared to BR regimen. No cancer detected in 40 of% of patients on Polivy, bendamustine, and Rituxan arm compared to 18% in patients on BR regimen.


The FDA's Accelerated Approval Program is granted for drugs which are indicated for diseases with high unmet needs.

Please donate to support iPharmaCenter. Click on donate button in header to support us. Thank you

©2020 by ipharmaservices