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FDA approves new use for Jemperli plus chemo
FDA approves new use for Jemperli plus chemo.
About this update from Gsk Plc
[{"type":"text","content":"\n\nIssued: 31 July 2023, London UK\n \nJemperli (dostarlimab) plus chemotherapy approved in the US as the first new frontline treatment option in decades for dMMR/MSI-H primary advanced or recurrent endometrial cancer\n \n· Jemperli is the only immuno-oncology treatment approved in the frontline setting for this patient population in combination with chemotherapy\n· Patients with this type of endometrial cancer face significant unmet need and typically experience poor long-term outcomes with the current standard of care \n\n \n \nGSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved Jemperli (dostarlimab) in combination with carboplatin and paclitaxel, followed by Jemperli as a single agent for the treatment of adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR), as determined by an FDA-approved test, or microsatellite instability-high (MSI-H). The supplemental Biologics License Application (sBLA) supporting this new 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 of Oncology Development, GSK, said: \"Today's expanded approval of Jemperli redefines the treatment landscape for patients with dMMR/MSI-H primary advanced or recurrent endometrial cancer. Until now, chemotherapy alone has been the standard of care with many patients experiencing disease progression. In the RUBY trial, Jemperli plus chemotherapy demonstrated a 71% reduction in the risk of disease progression or death versus chemotherapy in this patient population, providing a statistically significant and clinically meaningful benefit. These results and today's approval underscore our belief in the potential for Jemperli to transform cancer treatment as a backbone immuno-oncology therapy.\"\n \nWith this approval, Jemperli is now indicated earlier in treatment in combination with chemotherapy for patients with dMMR/MSI-H primary advanced or recurrent endometrial cancer. Jemperli is already approved in the US as monotherapy in adult patients with dMMR recurrent or advanced endometrial cancer that has progressed on or following a prior platinum-containing regimen in any setting and a...