GSK plc (NYSE: GSK), a major UK pharmaceutical company, has announced that the US Food and Drug Administration (FDA) has granted market approval for its programmed death-1 (PD-1) inhibitor, Jemperli (dostarlimab), as a first-line treatment for advanced or recurrent endometrial cancer. This indication is for patients who are to first receive Jemperli in combination with carboplatin and paclitaxel chemotherapy, followed by Jemperli as a single agent. The disease must be mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) to qualify for this treatment protocol.
Supporting Data from the RUBY Study
The FDA filing was supported by data from the RUBY study, which demonstrated that the combination of Jemperli and chemotherapy achieved a 71% reduction in the risk of disease progression or death compared to chemotherapy alone. The principal investigator involved in the study, as quoted by GSK, described the results as potentially “practice changing.” This significant outcome positions Jemperli as a groundbreaking treatment option for patients with advanced endometrial cancer.
Jemperli’s Expanding Indications in the US Market
The approval marks Jemperli’s third indication in the US market, following earlier approvals for second-line use in dMMR endometrial cancer and for adults with dMMR advanced or recurrent solid tumors. This expansion of Jemperli’s approved uses underscores GSK’s commitment to advancing immunotherapies and providing new treatment options for patients battling various types of cancer.-Fineline Info & Tech
