GSK reports FDA grants expanded approval of Jemperli

GSK plc announced that the U.S. Food and Drug Administration has approved Jemperli 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, or dMMR, as determined by an FDA-approved test, or microsatellite instability-high, or MSI-H. The supplemental Biologics License Application, or sBLA, supporting this new indication received Priority Review and was approved ahead of the Prescription Drug User Fee Act action date, the company noted. Hesham 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.”