GSK announces FDA granted BTD for Jemperli

GSK (GSK) announced that the US Food and Drug Administration, FDA, has granted Breakthrough Therapy Designation, BTD, for Jemperli for the treatment of patients with locally advanced mismatch repair deficient/microsatellite instability-high, MSI-H, rectal cancer. The Breakthrough Therapy Designation aims to expedite the development and review of drugs with the potential to treat a serious condition and where preliminary clinical evidence may indicate substantial improvement over currently available therapy. This is the second regulatory designation for dostarlimab in locally advanced dMMR/MSI-H rectal cancer, following Fast Track designation for the same patient population in January 2023.