GSK says FDA expands Jemperli plus chemotherapy approval to new indication

GSK plc announced the Food and Drug Administration has approved Jemperli in combination with carboplatin and paclitaxel chemotherapy followed by Jemperli as a single agent for the treatment of adult patients with primary advanced or recurrent endometrial cancer. “This approval broadens the previous indication for Jemperli plus chemotherapy to include patients with mismatch repair proficient/microsatellite stable tumors who represent 70-75% of patients diagnosed with endometrial cancer and who have limited treatment options. The supplemental Biologics License Application, or sBLA, supporting this expanded indication received Priority Review and was approved ahead of the Prescription Drug User Fee Act action date,” the company stated. Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK, said: “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 70-75% with MMRp/MSS tumors where treatment options have been limited.”