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Approval alert: Genentech’s Columvi® (glofitamab) approved for R/R DLBCL by FDA

Jun 15, 2023

Genentech announced that the FDA approved Columvi® (glofitamab-gxbm) for the treatment of adults with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) not otherwise specified or large B-cell lymphoma (LBCL) arising from follicular lymphoma, after two or more lines of systemic therapy.  The FDA approved Columvi® under the accelerated approval pathway based on a phase I/II clinical trial.  Genentech confirmed that Columvi® will be available in the US in the coming weeks.

On 26 April 2023, the EMA’s Committee for Medicinal Products for Human Use recommended approval of Columvi® for R/R DLBCL.