FDA accepts supplemental Biologics License Application for Roche ’s Polivy combination for people with previously untreated diffuse large B-cell lymphoma

First new treatment regimen in more than 20 years to significantly improve outcomes in people with this fast-growing type of lymphomaApplication is based on pivotal data from the phase III POLARIX study showing Polivy plus R-CHP significantly reduced therisk of disease progression, relapse or death with comparable safety versus the standard of care, R-CHOPVarious combination studies with Polivy and the company ' s CD20xCD3 bispecifics in diffuse large B-cell lymphoma are ongoingBasel, 16 August 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has accepted the company ’s supplemental Biologics License Application (sBLA) for Polivy® (polatuzumab vedotin-piiq) in combination with Rituxan® (rituximab) plus cyclophosphamide, doxorubicin and prednisone (R-CHP) for the treatment of people with previously untreated diffuse large B-cell lymphoma (DLBCL). The FDA is e xpected to make a decision on approval by 2 April 2023.“The POLARIX study results suggest that Polivy plus R-CHP could transform the treatment of this aggressive malignancy, and we are working with the FDA to bring this combination to newly diagnosed DLBCL patients as soon as possible,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Office r and Head of Global Product Development. “We hope it will become the new standard of care for the first-line treatment of DLBCL, potentially reducing the need for subsequent treatments and limiting patient bu...
Source: Roche Media News - Category: Pharmaceuticals Source Type: news