FDA green light for GSK's endometrial cancer drug Jemperli

The US Food and Drug Administration has approved UK pharma major GSK’s (LSE: GSK) Jemperli (dostarlimab-gxly)) with carboplatin and paclitaxel, followed by single-agent dostarlimab-gxly, for primary advanced or recurrent endometrial cancer (EC) that is mismatch repair deficient (dMMR), as determined by an FDA-approved test, or microsatellite instability-high (MSI-H).

The supplemental Biologics License Application (sBLA) supporting this new indication received Priority Review and was approved well ahead of the Prescription Drug User Fee Act action date of September 23.

Until now, in endometrial cancer, Jemperli has been approved in the USA as monotherapy in dMMR recurrent or advanced endometrial cancer that has progressed on or following a prior platinum-containing regimen.