罗氏CD79b ADC在华获批新适应症

Core Insights - The approval of Polatuzumab vedotin in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (Pola-R-CHP) for the treatment of previously untreated DLBCL adult patients marks a significant advancement in the field [1] - The Pola-BR regimen, combining Polatuzumab vedotin with bendamustine and rituximab, is also approved for adult patients with relapsed or refractory DLBCL who are not suitable for hematopoietic stem cell transplantation [1] - The Pola-R-CHP regimen has received first-level recommendations in multiple authoritative guidelines and has been included in the National Reimbursement Drug List (NRDL), establishing it as a standard treatment for DLBCL [1] Clinical Study Findings - The approval is based on a global multicenter, randomized controlled phase III clinical trial comparing the efficacy and safety of Pola-R-GemOx regimen against R-GemOx regimen [1] - Patients receiving Polatuzumab vedotin showed a significant improvement in overall survival (OS) with a median OS of 19.5 months (HR=0.60, p=0.0017), indicating a 40% reduction in the risk of death [1] - The median progression-free survival (PFS) for the Polatuzumab vedotin group was 7.4 months (HR=0.37, p<0.0001), demonstrating a 63% reduction in the risk of disease progression [1] - The benefits of the Pola-R-GemOx regimen were consistent across the entire population studied [1]