GSK’s Jemperli scores FDA approval in rectal cancer, backed by high complete response rate

FDA grants accelerated approval to dostarlimab for dMMR rectal cancer

The FDA has granted accelerated approval to dostarlimab-gxly (Jemperli) as monotherapy for adults with previously untreated stage II or III locally advanced rectal cancer with dMMR or MSI-H status, based on interim phase 2 AZUR-1 trial results. This marks a first-in-class approval in this specific type of rectal cancer.