FDA grants regular approval for GSK's Jemperli in dMMR endometrial cancer

Given the spate of non-conversions of accelerated approvals by the US regulator, there was good news yesterday for UK pharma major GSK (LSE: GSK) regarding Jemperli (dostarlimab-gxly), as the company’s ambition is for the drug to become the backbone of its ongoing immuno-oncology-based R&D program.

The Food and Drug Administration (FDA) granted full approval for GSK’ Jemperli for adult patients with mismatch repair deficient (dMMR) recurrent or advanced endometrial cancer, as determined by an FDA-approved test, that has progressed on or following a prior platinum-containing regimen in any setting and are not candidates for curative surgery or radiation.

In April 2021, dostarlimab-gxly received accelerated approval for adult patients with dMMR recurrent or advanced endometrial cancer, as determined by an FDA-approved test, that has progressed on or following a prior platinum-containing regimen. The agency’s Accelerated Approval Program allows patients to access innovative new drugs while the manufacturer and FDA conduct additional studies to confirm the product’s clinical benefit.