FDA priority review for GSK's Jemperli in early-stage dMMR/MSI-H rectal cancer

The US Food and Drug Administration (FDA) has accepted for priority review a supplemental Biologics License Application (sBLA) for GSK's (LSE: GSK) Jemperli (dostarlimab) in previously untreated stage II and III mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) locally advanced rectal cancer.

A target action date of February 2027 has been set by the regulator, and the application remains eligible for further expedited review under the National Priority Voucher program.