[Ad hoc announcement pursuant to Art. 53 LR] FDA approves Roche ’s Polivy in combination with R-CHP for people with certain types of previously untreated diffuse large B-cell lymphoma

Polivy combination is the first FDA-approved therapy in nearly 20 years for the first-line treatment of diffuse large B-cell lymphoma, an aggressive disease and the most common form of non-Hodgkin lymphoma in the USPOLARIX trial showed thePolivy combination reduced the risk of disease progression, relapse or death by 27% compared to the standard of care, R-CHOP, with a comparable safety profileFirst-line treatment withPolivy plus R-CHP has the potential to reduce the burden on patients and healthcare systems, associated with disease progressionBasel, 19 April 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (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 (NOS) or high-grade B-cell lymphoma (HGBL) an d who have an International Prognostic Index (IPI) score of two or greater. 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.DLBCL is an aggressive, hard-to-treat disease and is the most common form of non-Hodgkin lymphoma in the United States. Approximately 31,000 people in the US are projected to be diagnosed with DLBCL in 2023. Limited progress has ...
Source: Roche Investor Update - Category: Pharmaceuticals Source Type: news