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Jemperli full FDA approval following GARNET trial
Jemperli full FDA approval following GARNET trial.
About this update from Gsk Plc
[{"type":"text","content":"\n \n \n 10 February 2023, London UK\n \n \n \n \n \n \n \n \n US FDA grants\n \n \n regular\n \n \n approval for Jemperli for the treatment of patients with recurrent or advanced mismatch repair-deficient endometrial cancer\n \n \n \n \n \n \n ·\n Conversion from accelerated to\n regular (\n full\n ) approval\n based on long-term outcomes from the GARNET phase I trial, which demonstrated an overall response rate of 45.4%\n \n \n ·\n 85.9% of patients had duration of response ≥12 months and 54.7% of patients had duration of response ≥24 months\n \n \n \n \n \n \n \n \n \n \n \n \n GSK plc (LSE/NYSE: GSK) today reports that the US Food and Drug Administration (FDA) granted full approval for Jemperli (dostarlimab-gxly) for the treatment of adult patients with mismatch repair-deficient (dMMR) recurrent or advanced endometrial cancer, as determined by a US 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.\n \n \n \n \n \n \n Hesham Abdullah, Senior Vice President, Global Head of Oncology Development, GSK, said:\n \n \"\n This\n US regulatory action confirms our confidence in Jemperli as an important treatment option for patients with dMMR recurrent or advanced endometrial cancer. We continue to unlock the potential of Jemperli as the backbone for our immuno-oncology development programmes to address the unmet needs of patients\n ,\n including earlier lines of endometrial cancer and other solid tumours.\"\n \n \n \n \n \n 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.\n \n \n \n \n \n This approval is based on additional data collected from the A1 expansion cohort of the ongoing GARNET trial, a phase I, multicentre, open-label, single-arm study of Jemperli monotherapy in patients with advanced or recurrent solid tumours. Cohort A1 evaluated the efficacy of Jemperli in 141 patients with dMMR advanced or recurrent endometrial cancer that has progressed on or following prior treatment with a platinum-containing regimen. The major efficacy outcome measures were overall response rate (ORR) and duration of r...