FDA ODAC Votes Against the Applicability of STARGLO Data for Glofitamab + Chemo for Patients With R/R DLBCL
“Columvi in combination with GemOx demonstrated a 41% reduction in risk of death in a Phase III, randomized, multiregional clinical trial, supporting its recent approval by the European Commission and inclusion in the U.S. National Comprehensive Cancer Network treatment guidelines as a category 1 preferred regimen,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “We believe the STARGLO results are applicable to U.S. patients, with the global study population closely mirroring the real-world clinical profile of DLBCL patients in the U.S., and we will continue working with the FDA on the regulatory path forward.”
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