Posted by Michael Wonder on 16 Aug 2022
FDA accepts supplemental biologics license application for Genentech's Polivy combination for people with previously untreated diffuse large B-cell lymphoma
15 August 2022 - Application is based on pivotal data from the Phase 3 POLARIX study showing Polivy plus R-CHP significantly reduced the risk of disease progression, relapse or death with comparable safety versus the standard of care, R-CHOP.
Genentech today announced that the US FDA has accepted the company’s supplemental biologics license application for Polivy (polatuzumab vedotin-piiq) in combination with Rituxan (rituximab) plus cyclophosphamide, doxorubicin and prednisone for the treatment of people with previously untreated diffuse large B-cell lymphoma.
The FDA is expected to make a decision on approval by 2 April 2023.
