FDA Accelerates Organ-Preservation Path for Biomarker-Defined Rectal Cancer

Company GSK Event Type Regulatory (FDA Accelerated Approval) Modality Anti-PD-1 monoclonal antibody Asset Dostarlimab-gxly (Jemperli) Target PD-1 Disease Area Stage II or III MSI-H/dMMR locally advanced rectal cancer Summary The US Food and Drug Administration granted accelerated approval to dostarlimab-gxly for adults with previously untreated…