FDA expands GSK’s Jemperli approval for endometrial cancer
GSK has announced that Jemperli (dostarlimab) plus chemotherapy has obtained expanded approval from the US Food and Drug Administration (FDA) for treating adult patients with primary advanced or recurrent endometrial cancer. The decision now includes patients with mismatch repair proficient (MMRp)/microsatellite stable (MSS) tumours, who make up 70 to 75% of diagnosed cases and previously had limited treatment options.
The treatment regimen comprises Jemperli plus chemotherapy with carboplatin and paclitaxel followed by Jemperli as monotherapy.
The supplemental biologics licence Application (sBLA) for this indication previously received priority review and was approved before the Prescription Drug User Fee Act action date. GSK received the approval based on the data from the RUBY Phase III trial’s Part 1 results from dual primary endpoints of progression-free survival and overall survival (OS).
According to the findings, a significant overall survival (OS) benefit in the full population of patients with primary advanced or recurrent endometrial cancer was reported.
In the Part 1 portion, the treatment regimen also demonstrated a 31% decline in death risk compared to chemotherapy alone. At the two-and-a-half-year mark, 61% of patients treated with Jemperli and chemotherapy were alive versus 49% in the chemotherapy group. A median OS improvement of 16.4 months was observed with Jemperli plus chemotherapy.
The safety profile of Jemperli and carboplatin-paclitaxel was consistent with the known profiles of the individual agents.
GSK global head of oncology research and development senior vice-president Hesham Abdullah stated: “Jemperli 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 to 75% with MMRp/MSS tumours where treatment options have been limited.”
In June 2024, the US FDA expanded the age indication for GSK‘s Arexvy, an respiratory syncytial RSV vaccine, now available for adults aged 50 to 59 years at higher risk of lower respiratory tract disease.
August 5, 2024
