FDA issues CRL for Supplemental BLA for Columvi® (glofitamab-gxbm) + GemOx combo for R/R DLBCL patients not candidates for autoSCT
“While we are disappointed with this outcome, we remain confident in the data supporting the value of Columvi for U.S. patients who have relapsed following initial treatment, and its key role as monotherapy in the third-line setting,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “We are committed to bringing Columvi to more people living with lymphoma and are actively exploring its potential in additional treatment settings, including as frontline therapy.”
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