FDA Prioritizes GSK's Breakthrough Drug Jemperli for Endometrial Cancer Treatment, a First in Decades
Portfolio Pulse from Vandana Singh
The FDA has accepted GSK's supplemental marketing application for Jemperli (dostarlimab) in combination with chemotherapy for the treatment of adult patients with advanced or recurrent endometrial cancer. The FDA granted Priority Review and assigned a Prescription Drug User Fee Act action date of 23 September. Jemperli was also recently granted Breakthrough Therapy designation.
June 06, 2023 | 1:36 pm
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GSK's Jemperli receives FDA Priority Review and Breakthrough Therapy designation for endometrial cancer treatment, potentially representing the first meaningful frontline treatment advancement in decades.
The FDA's acceptance of GSK's Jemperli for endometrial cancer treatment, along with the Priority Review and Breakthrough Therapy designation, indicates a positive outlook for the drug's approval. If approved, it could represent a significant advancement in endometrial cancer treatment, potentially boosting GSK's stock price in the short term.
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