GSK receives FDA OK for new Jemperli indication

GSK has received the Food and Drug Administration’s green light for Jemperli (dostarlimab-gxly) for the treatment of adult patients with mismatch repair-deficient recurrent or advanced endometrial cancer, as determined by an FDA-approved test, that has progressed on or following a prior platinum-containing regimen in any setting and are not candidates for curative surgery or radiation.

"This U.S. regulatory action confirms our confidence in Jemperli as an important treatment option for patients with dMMR recurrent or advanced endometrial cancer," said Hesham Abdullah, senior vice president of global head of oncology development at GSK. "We continue to unlock the potential of Jemperli as the backbone for our immuno-oncology development programs to address the unmet needs of patients, including earlier lines of endometrial cancer and other solid tumors."

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In April 2021, Jemperli received accelerated approval for the treatment of adult patients with dMMR recurrent or advanced endometrial cancer that had progressed on or following prior treatment with a platinum-containing regimen.