• Designation based on data showing no evidence of disease in 100% of all 42 patients who completed treatment with dostarlimab
• Breakthrough Therapy Designation granted to drugs with potential to show improvement over available therapies for serious conditions
• Current standard of care can be associated with significant negative quality-of-life effects, highlighting the need for new options

GSK plc (LSE/NYSE: GSK) announced today that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for Jemperli (dostarlimab) for the treatment of patients with locally advanced mismatch repair deficient (dMMR)/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.1 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 2023.2

Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK, said: “Today’s designation, which is based on the unprecedented 100% clinical complete response rate of dostarlimab reported to date, supports a path to help change the treatment paradigm for patients with locally […]