The US Food and Drug Administration (FDA) denied the supplemental Biologics License Application (sBLA) for glofitamab combined with gemcitabine and oxaliplatin (GemOx) for relapsed or refractory diffuse large B-cell lymphoma (DLBCL) in patients ineligible for stem cell transplant after one prior therapy.
The FDA found the STARGLO study’s data insufficient for the second-line DLBCL indication in the United States. The study, meant to confirm glofitamab’s accelerated approval for third-line or later DLBCL, showed a 41% lower risk of death compared to rituximab plus GemOx, as reported in The Lancet and presented at ASCO 2025. Glofitamab retains accelerated approval for third-line or later DLBCL.
In May 2024, a federal advisory panel voted 8-1 that results from the global STARGLO trial, which was intended as the confirmatory trial for full approval of glofitamab-gxbm, were not applicable to the US patient population.
The glofitamab-GemOx combination is approved in over 35 countries, including the European Union, and recommended by NCCN Guidelines for relapsed or refractory DLBCL. Genentech, the manufacture, is testing glofitamab in untreated large B-cell lymphoma through the SKYGLO study to meet FDA postmarketing requirements.
