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

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

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.

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 expanded label for Roche's cancer drug Columvi

The FDA issued a complete response letter to Roche’s Columvi, saying the data that the company provided for the label expansion aren't sufficient. Roche’s Genentech had been seeking approval for Columvi in combination with gemcitabine ...