GSK’s Jemperli Granted FDA Priority Review for dMMR/MSI-H Locally Advanced Rectal Cancer
GSK plc announced that the US Food and Drug Administration (FDA) has accepted its supplemental Biologics License Application (sBLA) for priority review of Jemperli (dostarlimab) as a potential treatment for patients with previously untreated stage II or III mismatch repair-deficient (dMMR)/microsatellite instability-high (MSI-H) locally advanced rectal cancer. The FDA has set a PDUFA action date for February 2027. The application is also eligible for expedited assessment under the National Priority Voucher program, which may enable an earlier regulatory decision.
Rectal canc...