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FDA Expands Jemperli Approval
FDA Expands Jemperli Approval.
About this update from Gsk Plc
[{"type":"text","content":"\n\nIssued: 1 August 2024, London UK\n \nUS FDA expands Jemperli (dostarlimab) plus chemotherapy approval to all adult patients with primary advanced or recurrent endometrial cancer as the first and only immuno-oncology-based treatment to show an overall survival benefit \n \n\nJemperli approval now includes MMRp/MSS tumours, which represent majority of endometrial cancer cases\n\n\nJemperli plus chemotherapy demonstrated a statistically significant and clinically meaningful 31% reduction in risk of death versus chemotherapy alone\n\n \n \n \nGSK plc (LSE/NYSE: GSK) today announced the US Food and Drug Administration (FDA) has approved Jemperli (dostarlimab) in combination with carboplatin and paclitaxel (chemotherapy) followed by Jemperli as a single agent for the treatment of adult patients with primary advanced or recurrent endometrial cancer. This approval broadens the previous indication for Jemperli plus chemotherapy to include patients with mismatch repair proficient (MMRp)/microsatellite stable (MSS) tumours who represent 70-75% of patients diagnosed with endometrial cancer and who have limited treatment options. The supplemental Biologics License Application (sBLA) supporting this expanded indication received Priority Review and was approved ahead of the Prescription Drug User Fee Act action date.\n \nHesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK, said: ÒJemperli plus chemotherapy is the first and only immuno-oncology regimen to show significant and meaningful improvement in overall survival for adult patients with primary advanced or recurrent endometrial cancer regardless of biomarker status. We are thrilled this option is now available for more patients in the US, including the 70-75% with MMRp/MSS tumours where treatment options have been limited.Ó\n \nTodayÕs expanded approval is based on results from dual primary endpoints of investigator-assessed progression-free...