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GSK plc announced that the US FDA has accepted a supplemental Biologics License Application for Jemperli (dostarlimab)…
GLAXFGSK plc
GSK plc announced that the US FDA has accepted a supplemental Biologics License Application for Jemperli (dostarlimab) for priority review to treat previously untreated stage II and III mismatch repair deficient or microsatellite instability-high locally advanced rectal cancer. The PDUFA action date is set for February 2027, with eligibility for the National Priority Voucher program potentially expediting the decision. The application relies on AZUR-1 trial data showing sustained clinical complete responses without detectable signs of cancer for at least one year. GSK plc operates in the global biopharmaceutical industry.