GSK Gets FDA File Acceptance For Jemperli Endometrial Cancer Treatment
June 06 2023 - 2:44AM
Dow Jones News
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)
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