GemOx (gemcitabine and oxaliplatin)

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Roche Gets Nod for Expanded Use of Columvi in Lymphoma in Europe
ZACKSยท 2025-04-14 14:55
Core Viewpoint - Roche's lymphoma drug Columvi has received European Commission approval for second-line treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) [1][2] Regulatory Approval - The approval was anticipated following a recommendation from the Committee for Medicinal Products for Human Use in February [2] - Columvi is also under review in the United States, with a decision expected on July 20, 2025 [2] Clinical Data - The approval is based on the pivotal phase III STARGLO study, which demonstrated a statistically significant improvement in overall survival when Columvi was used in combination with GemOx compared to MabThera/Rituxan with GemOx [5][6] - The combination treatment showed a 41% reduction in the risk of death versus R-GemOx [6] Safety Profile - The Columvi/GemOx combination exhibited a safety profile consistent with the individual medicines [7] Market Context - DLBCL is the most common form of non-Hodgkin's lymphoma, accounting for approximately one-third of all NHL cases, with an estimated 160,000 new diagnoses globally each year [9] Ongoing Research - Roche is also evaluating Columvi in combination with other treatments in the phase III SKYGLO study for previously untreated DLBCL patients [10] Stock Performance - Year to date, Roche's shares have increased by 9.3%, contrasting with a 6.7% decline in the industry [3]