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Home » In 8-to-5 Vote, FDA AdComm Greenlights GSK Rectal Cancer Trial
In 8-to-5 Vote, FDA AdComm Greenlights GSK Rectal Cancer Trial
The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 8 to 5 on Thursday to recommend allowing GSK to move forward with a single-arm trial to evaluate its immunotherapy dostarlimab-gxly (dostarlimab) for the treatment of patients with mismatch repair deficiency/microsatellite instability-high (dMMR/MSI-H) locally advanced rectal cancer (LARC).