Genentech and Roche announced that the FDA 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 approval converts the FDA’s previous accelerated approval of Polivy® in combination with bendamustine and Rituxan® for relapsed or refractory DLBCL into a regular approval.
We recently reported that Dr. Reddy’s was preparing to file BLA/MAA dossiers for rituximab biosimilar against Rituxan®.