FDA accepts supplemental Biologics License Application for Roche’s Polivy combination for people with previously untreated diffuse large B-cell lymphoma
The Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for polatuzumab vedotin-piiq in combination with rituximab plus cyclophosphamide, doxorubicin and prednisone (R-CHP) for the treatment of adults with previously untreated diffuse large B-cell lymphoma (DLBCL).
On August 16, 2022, Roche announced that the US FDA has accepted its antibody drug conjugate (ADC) Polivy (polatuzumab vedotin) in combination with R-CHP for the treatment of disseminated large B cells that have not received any prior treatment. Supplemental Biologics License Application (sBLA) for patients with lymphoma (DLBCL). The FDA expects to complete the review by April 2, 2023.
According to the press release, this will likely be the first new first-line treatment in more than 20 years to significantly improve outcomes for patients with this rapidly progressive lymphoma. The sBLA application is based on the results of the POLARIX Phase 3 clinical trial. This is the first trial in 20 years to show a clinically meaningful improvement in progression-free survival (PFS) compared to the existing standard of care, R-CHOP, the press release noted.
