FDA considers Columvi combo in earlier treatment setting

The US Food and Drug Administration has accepted a supplemental Biologics License Application for Roche's (ROG: SIX) Columvi (glofitamab) in combination with chemo.

The Swiss cancer giant is developing the therapy for certain people with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), as a second-line option.

The agency will review findings from the Phase III STARGLO study, which demonstrated that the therapy significantly improved overall survival compared to a Rituxan (rituximab)-chemo regimen. A decision is expected by July 2025.