FDA Grants Breakthrough Status to GSK’s Jemperli

GSK has announced that its immunotherapy, Jemperli (dostarlimab), has been granted Breakthrough Therapy Designation by the FDA for treating patients with locally advanced dMMR/MSI-H rectal cancer. This decision was supported by preliminary data from a trial showing an unprecedented 100% clinical complete response (cCR) in 42 patients. These promising results suggest potential to revolutionize the treatment approach for this cancer type.

Current standard treatment involves chemotherapy, radiation, and surgery, often resulting in significant long-term quality-of-life challenges. GSK's ongoing AZUR-1 trial aims to validate these groundbreaking findings.