GSK Gets FDA File Acceptance For Jemperli Endometrial Cancer Treatment
By Anthony O. Goriainoff
GSK said Tuesday that the U.S. Food and Drug Administration has accepted the supplemental Biologics License Application for its Jemperli endometrial cancer treatment in combination with chemotherapy.
The London-listed pharmaceutical giant said the FDA has granted the application a priority review which has a Prescription Drug User Fee Act, or PDUFA, action date of Sept. 23.
The PDUFA refers to the date by which the agency's review process must be completed.
The company said that if approved the treatment plus chemotherapy could represent a meaningful front-line treatment advancement for patients with primary advanced or recurrent endometrial cancer.
Write to Anthony O. Goriainoff at anthony.orunagoriainoff@dowjones.com
(END) Dow Jones Newswires
June 06, 2023 02:29 ET (06:29 GMT)
Copyright (c) 2023 Dow Jones & Company, Inc.-
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