FDA approves Roche's Polivy combo for frontline B-cell lymphoma

Following a positive advisory committee meeting last month, the US Food and Drug Administration (FDA) has approved Polivy (polatuzumab vedotin-piiq).

Developed by Swiss pharma giant Roche (ROG: SIX), Polivy is cleared for use 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 (NOS) or high-grade B-cell lymphoma (HGBL) and who have an International Prognostic Index (IPI) score of two or greater. T

This FDA decision converts the accelerated approval of Polivy in combination with bendamustine and Rituxan for relapsed or refractory (R/R) DLBCL after at least two prior therapies to regular approval.