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.