(News Bulletin 247) – GSK announces that the U.S. Food and Drug Administration (FDA) has accepted the Supplemental Biologics License Application for Jemperli (dostarlimab) in combination with chemotherapy for the treatment of endometrial cancer advanced or recurrent primary.
If approved in this patient population, Jemperli plus chemotherapy could represent the first significant advance in first-line treatment in decades for patients with advanced or recurrent primary endometrial cancer.
The FDA granted priority review to this application and assigned a Prescription Drug User Fee Act action date of September 23, 2023. Jemperli also recently obtained Breakthrough Therapy designation for this potential new indication.
Hesham Abdullah, senior vice president, global head of oncology development at GSK, said: ‘There is an urgent need to evolve the current standard of care, which is platinum-based chemotherapy.’
In April, the European Medicines Agency (EMA) validated GSK’s marketing authorization application for Jemperli plus chemotherapy for the treatment of advanced or recurrent primary endometrial cancer.
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