Posted by Michael Wonder on 19 Apr 2023
FDA approves Genentech's Polivy in combination with R-CHP for people with certain types of previously untreated diffuse large B-cell lymphoma
19 April 2023 - Polarix trial showed the Polivy combination reduced the risk of disease progression, relapse or death by 27% compared to the standard of care, R-CHOP, with a comparable safety profile.
Genentech announced today that the US FDA has approved Polivy (polatuzumab vedotin-piiq) in combination with Rituxan (rituximab), cyclophosphamide, doxorubicin and prednisone (R-CHP) for the treatment of adult patients who have previously untreated diffuse large B-cell lymphoma (DLBCL), not otherwise specified or high-grade B-cell lymphoma and who have an International Prognostic Index score of two or greater.
This FDA decision converts the accelerated approval of Polivy in combination with bendamustine and Rituxan for relapsed or refractory DLBCL after at least two prior therapies to regular approval.
