CHMP recommends EU approval of Roche ’s Polivy combination for people with previously untreated diffuse large B-cell lymphoma

Polivy plus R-CHP showed first clinically meaningful improvement in PFS with comparable safety in people with previously untreated diffuse large B-cell lymphoma (DLBCL) over the standard of care in more than 20 yearsApproximately 40% of people with previously untreated DLBCL are not cured with the current standard of care and face a poor prognosis [1,2]Recommendation is based on pivotal data from the phase III POLARIX studyBasel, 25 March 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Medicines Agency ’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Polivy® (polatuzumab vedotin) in combination with MabThera® (rituximab) plus cyclophosphamide, doxorubicin, and prednisone (R-CHP) for the treatment of previously untreated diffuse large B-cell lymphoma (DLB CL). Polivy plus R-CHP is the first treatment regimen to significantly improve outcomes in this disease in more than 20 years. A final decision regarding the approval of this Polivy combination is expected from the European Commission in the near future.DLBCL is the most common form of non-Hodgkin lymphoma and it is estimated 40,000 people in Europe are diagnosed with the disease each year.[3,4] Approximately four out of ten patients will relapse after first line treatment and the majority of patients who require subsequent lines of therapy have poor outcomes.[1,2]“A significant proportion of people newly diagnosed with diffuse large B-cell lymphoma, an...
Source: Roche Media News - Category: Pharmaceuticals Source Type: news