GSK's endometrial cancer drug gets expanded US approval
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GSK said the US Food and Drug Administration has approved its Jemperli treatment in combination with chemotherapy and then use on its own for adult patients with primary advanced or recurrent endometrial cancer.
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The approval broadens the previous indication for Jemperli plus chemotherapy to include patients with mismatch repair proficient (MMRp)/microsatellite stable (MSS) tumours who represent 70-75% of patients diagnosed with endometrial cancer and who have limited treatment options, GSK said on Friday.
It added that the approval is based on results from dual primary endpoints of investigator-assessed progression-free survival and overall survival from Part 1 of the global RUBY phase III trial.
Endometrial cancer is found in the inner lining of the uterus, and is the most common gynaecologic cancer in developed countries, with an estimated 1.6 million people living with active disease at any stage and 417,000 new cases reported each year worldwide.
Incidence rates are expected to rise by approximately 40% between 2020 and 2040.
Reporting by Frank Prenesti for Sharecast.com