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The U.S. Food and Drug Administration (FDA) granted full approval to GSK’s (NYSE:GSK) Jemperli converting it from accelerated approval to treat certain patients with a type of endometrial cancer.
Jemperli (dostarlimab-gxly) received full approval to treat adult patients with mismatch repair-deficient (dMMR) recurrent or advanced endometrial cancer — determined by a FDA-approved test —which has progressed on or after a prior platinum-containing regimen in any setting and are not candidates for curative surgery or radiation.
Jemperli received accelerated approval from the FDA in April 2021 to treat a similar population.
The British pharma giant said that the approval was backed by data from an ongoing phase 1 trial, dubbed GARNET.
“This US 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, global head of Oncology Development, GSK.
In December 2022, Jemperli had met the main goal of progression-free survival (PFS) in patients with primary advanced or recurrent endometrial cancer in a phase 3 trial called RUBY.
Endometrial cancer is found in the inner lining of the uterus known as the endometrium.
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