Jemperli Granted FDA Approval in Endometrial Cancer Applications
GSK has announced the FDA has granted full approval for its treatment for patients with dMMR recurrent or advanced endometrial cancer.
Its therapeutic, Jemperli (dostarlimab-gxly), is now cleared for use for adult patients with mismatch repair-deficient (dMMR) recurrent or advanced endometrial cancer who are not candidates for curative surgery or radiation.
Hesham Abdullah, Senior Vice President and Global Head of Oncology Development at GSK, described Jemperli as the backbone of the company's immuno-oncology programmes.
“This US regulatory action confirms our confidence in Jemperli as an important treatment option for patients with dMMR recurrent or advanced endometrial cancer,” Abdullah said in a press release.
Approval from the FDA came following additional data collected from the AI expansion cohort of an ongoing GARNET trial, which investigates the efficacy of Jemperli monotherapy in patients with advanced or recurrent solid tumours.
Jemperli functions as a programmed death receptor-1 (PD-1) agonist, which acts as an immune checkpoint inhibitor in T cells.
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PD-1 is a checkpoint protein on T cells, which functions to prevent the T cells from attacking other cells in the body.
Some cancer cells have large amounts of PD-L1, which obscures them from immune attack.
When administered, Jemperli binds to a tumour's PD-1 receptor and interrupts its interaction with the PD-1 ligands PD-L1 and PD-L2.
Following FDA approval for the use of Jemperli in the context of patients with dMMR recurrent or advanced scenarios, the therapeutic's applications are being investigated in registrational enabling studies as monotherapy and as part of combination regimens.
Endometrial cancer occurs in the endometrium - the inner lining of the uterus.
With approximately 417,000 new cases reported each year worldwide, endometrial cancer is the most common gynaecologic cancer globally.
Approximately one fifth of patients with endometrial cancer will be diagnosed with advanced disease at the time of the diagnosis.
GSK continues to focus on exploring other applications of Jemperli for addressing the unmet needs of patients, including in earlier lines of endometrial cancer and other solid tumours.
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