GSK plc（GSK）資訊與事件GSKGSK plc

GSK's Jemperli Receives FDA Accelerated Approval for Advanced Rectal Cancer

GSK announced the U.S. FDA has approved Jemperli as the first and only immunotherapy for adults with stage II and III microsatellite instability-high/mismatch repair deficient locally advanced rectal cancer under the accelerated approval pathway. Jemperli has received FDA Fast Track and Breakthrough Therapy designations for this indication. The application was also granted Priority Review and received a National Priority Voucher, resulting in an accelerated approval ahead of the PDUFA date.

AnaptysBio Announces GSK Receives FDA Approval for Jemperli

AnaptysBio (ANAB), a company focused on managing the financial collaborations for Jemperli with Tesaro, a GSK (GSK) company, and Quimilza with Vanda, announced that GSK has received U.S. Food and Drug Administration approval for Jemperli as the first and only immunotherapy for adults with stage II and III microsatellite instability-high/ mismatch repair deficient locally advanced rectal cancer. GSK plans to present full data from the AZUR-1 interim analysis as a late-breaking abstract at ESMO Congress 2026 in Madrid, Spain on October 25, AnaptysBio noted.

GSK's Jemperli Receives FDA Accelerated Approval for Advanced Rectal Cancer

GSK announced the Food and Drug Administration has approved Jemperli as "the first and only immunotherapy" for adults with stage II and III microsatellite instability-high/mismatch repair deficient locally advanced rectal cancer under the accelerated approval pathway. Tony Wood, Chief Scientific Officer, GSK, said:"Today, Jemperli becomes the first and only approved immunotherapy for adults in the US with MSI-H/dMMR locally advanced rectal cancer. For decades, treatment has relied on chemotherapy, radiation and surgery. This approval offers a new treatment approach and represents an important step towards more personalised care for these patients."