Diffuse large B-cell lymphoma ( DLBCL) is the most common type of non-Hodgkin lymphoma (NHL), accounting for 31%–34% of NHL cases globally and 45.8% in China. The incidence rate increases with age. Even after first-line treatment, 30%–40% of DLBCL patients face relapse or refractory outcomes, resulting in a poor prognosis and challenging survival.On March 13, 2026, according to the latest announcement on the official website of the National Medical Products Administration (NMPA) of China , Roche (China) Investment Co., Ltd. 's application for a new indication for injectable veportuzumab has been approved for marketing in China . According to Roche's press release, the indication is: this product in combination with rituximab , gemcitabine, and oxaliplatin (Pola-R-GemOx) for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not suitable for hematopoietic stem cell transplantation. Public information shows that vedotin (Urithema®, Polivy®) is an antibody-drug conjugate (ADC) targeting CD79b developed by Roche, and is the world's first approved CD79b- targeting ADC . In 2019, the drug was approved by the US FDA for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL). In January 2023, China's NMPA approved it in combination with the R-CHP regimen (including rituximab, cyclophosphamide, doxorubicin, etc.) for relapsed or refractory DLBCL patients who are ineligible for hematopoietic stem cell transplantation . It also became the first targeted drug in China in 20 years to cover first-line treatment of DLBCL .This approval is based on a global, multicenter, randomized, controlled Phase III clinical trial that evaluated the efficacy and safety of veportozumab in combination with rituximab, gemcitabine, and oxaliplatin (Pola-R-GemOx) compared to the R-GemOx regimen. The study results showed that the regimen successfully met the primary endpoint and all key secondary endpoints.Data showed that adding vepotuzumab to the standard chemotherapy regimen R-GemOx significantly improved overall survival (OS) and progression-free survival (PFS): median OS reached 19.5 months (HR=0.60, p=0.0017), with a 40% reduction in the risk of death; median PFS reached 7.4 months (HR=0.37, p<0.0001), with a 63% reduction in the risk of disease progression. Furthermore, this regimen demonstrated consistent benefit across the entire population, with significant OS and PFS benefits observed in both the ABC and GCB subgroups.First-line treatment for diffuse large B-cell lymphoma (DLBCL) typically involves rituximab in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP), but only 60% of patients are cured with this regimen. CD79b, a widely expressed antigen on the surface of malignant B cells, has become an important therapeutic target, and vepotentiumab is an antibody-drug conjugate (ADC) that targets CD79b.It is worth mentioning that in 2024, veportozumab was successfully included in the national medical insurance program, covering indications including: ① previously untreated adult patients with DLBCL; ② adult patients with relapsed or refractory DLBCL who are ineligible for hematopoietic stem cell transplantation , further improving the accessibility of the drug.Non-Hodgkin's lymphoma (NHL) is a group of malignant tumors of the lymphohematopoietic system. Its incidence is increasing year by year, making it a serious hematological malignancy that threatens human life and health. Diffuse large B-cell lymphoma (DLBCL) is the most common, accounting for approximately 25% to 50%. DLBCL is highly heterogeneous and aggressive. Even after first-line treatment, 30% to 40% of DLBCL patients may still relapse or become refractory. Once it progresses to relapsed or refractory (R/R), DLBCL progresses rapidly and has a high mortality rate, with a median survival of only 6.3 months. It remains a major challenge in clinical practice, and there is an urgent need to explore more effective treatment options.The approval of veportuzumab (Urita®) for a new indication in China marks China as the first country globally to approve this treatment. Due to its significant clinical benefits, it has not only received first-level recommendations from multiple authoritative guidelines both domestically and internationally, but has also been included in the National Reimbursement Drug List (NRDL), gradually becoming a standard first-line treatment for DLBCL, and is expected to bring good news to more cancer patients.

https://mp.weixin.qq.com/s/Ffs3rNUBciEwmRBsWbQydg