GSK’s Jemperli Supplemental Application Gets FDA Priority Review for Early-Stage Mismatch Repair-Deficient Rectal Cancer

GSK plc (GSK, GSK.L) said the U.S. Food and Drug Administration has accepted for priority review a supplemental Biologics License Application for Jemperli (dostarlimab) in patients with previously untreated stage II and III mismatch repair-deficient (dMMR) or microsatellite instability-high (MSI-H) locally advanced rectal cancer. The FDA has assigned a Prescription Drug User Fee Act target action date of February 2027. The company noted the application is eligible for expedited review through the National Priority Voucher program.

In a separate announcement, Japan’s Ministry of Health, Labour and Welfare approved Hibasgo (bepirovirsen), an antisense oligonucleotide, as a functional cure for chronic hepatitis B virus infection in adult patients who have completed at least six months of prior nucleos(t)ide analogue therapy and meet predefined viral markers.

At the most recent trading close on the London Stock Exchange, GSK shares were priced at 1,918.50 pence.

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