Core Viewpoint - Roche announced the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Columvi® (glofitamab) in combination with gemcitabine and oxaliplatin (GemOx) for treating adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are ineligible for autologous stem cell transplant [1][2] Company Overview - Roche has been developing medicines for blood diseases for over 25 years, with a focus on innovative treatment options for hematologic conditions [11] - The company has a broad portfolio that includes several approved therapies for blood cancers, such as MabThera®/Rituxan® and Polivy® [11] Product Information - Columvi is a bispecific antibody designed to engage T-cells and target B-cells, specifically targeting CD3 on T cells and CD20 on B cells [9] - The combination of Columvi with GemOx showed a 41% reduction in the risk of death compared to the standard treatment, MabThera®/Rituxan® with GemOx, in the pivotal phase III STARGLO study [3][8] - Columvi is designed to be an off-the-shelf treatment option, allowing for immediate availability for patients [2][6] Clinical Study Insights - The CHMP recommendation is based on the results from the phase III STARGLO study, which demonstrated significant overall survival improvement for patients treated with Columvi plus GemOx [3][8] - The study included a primary endpoint of overall survival and secondary endpoints such as progression-free survival and safety [7] Market Need - DLBCL is an aggressive form of lymphoma, with approximately 38,000 new cases diagnosed annually in Europe, and about 40% of patients relapsing after initial treatment [2][10] - There is a high unmet need for effective treatments that can be initiated quickly after relapse, highlighting the importance of Columvi as a new therapeutic option [6][10]
CHMP recommends EU approval of Roche's Columvi combination for people with relapsed or refractory diffuse large B-cell lymphoma