FDA Rejects Genentech’s Glofitamab-Gxbm for DLBCL, Stymied by Insufficient Evidence

FDA Delivers a CRL to Glofitamab for Relapsed/Refractory DLBCL

The FDA determined the data from STARGLO did not provide sufficient evidence to support approving glofitamab-gxbm (Columvi) in combination with gemcitabine and oxaliplatin to treat relapsed/refractory diffuse large B-cell lymphoma (DLBCL).

FDA rejects Genentech’s glofitamab-gxbm for DLBCL, stymied by insufficient evidence

The FDA issued a complete response letter to Genentech indicating it cannot approve the company’s biologic license application seeking approval for glofitamab-gxbm as a treatment for relapsed or refractory diffuse large B-cell lymphoma.In its letter, the agency cited that data from the phase 3 STARGLO study failed to provide sufficient evidence to support glofitamab-gxbm (Columvi) as

DLBCL: FDA Rejects BLA for Second-Line Glofitamab Combo

Among reasons for the rejection, the agency cited a lack of US patient representation in the STARGLO trial assessing glofitamab as a second-line treatment for DLBCL.

FDA Issues Complete Response Letter for Glofitamab in R/R DLBCL Combination Therapy

FDA issues a complete response letter for glofitamab's second-line DLBCL indication, highlighting ongoing scrutiny in oncology therapy approvals.

FDA Issues Complete Response Letter for Glofit-GemOx Application in Relapsed or Refractory DLBCL

The U.S. Food and Drug Administration (FDA) has issued […]

FDA Issues Complete Response Letter for Glofit-GemOx in R/R DLBCL

The CRL states that the STARGLO data do not provide sufficient evidence to support the second-line indication in the US patient population.