On August 7th, GlaxoSmithKline (GSK.US) Singapore announced that the Health Sciences Authority (HSA) of Singapore has approved a new indication for Jemperli (dostarlimab).
According to the news release from GlaxoSmithKline, on August 7th, GlaxoSmithKline (GSK.US) Singapore announced that the Health Sciences Authority (HSA) of Singapore has approved a new indication for Jemperli (dostarlimab), which is used in combination with carboplatin and paclitaxel to treat primary advanced or recurrent endometrial cancer patients with deficient mismatch repair (dMMR) or high microsatellite instability-high (MSI-H). Jemperli is a programmed death receptor-1 (PD-1) blocking antibody that binds to the PD-1 receptor and blocks its interaction with the ligands PD-L1 and PD-L2.
This approval makes Jemperli the first-line immune tumor treatment drug for primary advanced or recurrent endometrial cancer patients with dMMR/MSI-H in Singapore, and can be used for early treatment of these patients. Earlier, Jemperli had been approved by HSA in Singapore for the monotherapy of dMMR recurrent or advanced endometrial cancer adult patients who progressed in any situation in or after the previous platinum-containing regimen and were unsuitable for therapeutic surgery or radiotherapy.
Dr. Stephanie Cinthu Stephen Ambrose, Medical Director of GlaxoSmithKline Singapore, said: "Singapore's expanded regulatory approval for Jemperli redefines the treatment prospects for dMMR/MSI-H primary advanced or recurrent endometrial cancer patients in Singapore. So far, chemotherapy has been the standard treatment for many disease progression patients. In the GSK RUBY trial, Jemperli + chemotherapy showed a 72% lower risk of disease progression or death in this patient population compared to chemotherapy, providing statistically and clinically significant benefits. These results emphasize the potential of Jemperli to transform cancer treatment into backbone immune tumor treatment."
