GSK announced Thursday that Health Canada accepted its supplemental new drug submission for Jemperli (dostarlimab). The submission targets the treatment of previously untreated dMMR/MSI-H locally advanced rectal cancer.
Health Canada will conduct the review under its accelerated Notice of Compliance with Conditions (NOC/c) policy. The application is also part of Project Orbis, an international collaborative review initiative.
If approved, Jemperli could eliminate or delay the need for chemotherapy, radiation, and surgery. Approximately 5% to 10% of rectal cancer patients possess the dMMR/MSI-H subtype.
Data from the AZUR-1 study supports the submission. GSK stock recently traded near its yearly high as analysts turn positive on the company's oncology pipeline momentum.