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GSK’s Jemperli® (Dostarlimab) receives US FDA Breakthrough Therapy Designation

Dec 16, 2024

On 16 December 2024, GSK announced that the US FDA has granted Breakthrough Therapy Designation to Jemperli® (dostarlimab) for the treatment of patients with locally advanced mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) rectal cancer. 

Earlier this month, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended Jemperli® for first line treatment (with chemotherapy) of primary advanced or recurrent endometrial cancer. 

In August 2024, Jemperli® received an indication expansion from the US FDA as combination therapy with carboplatin and paclitaxel for treating primary advanced or recurrent endometrial cancer.