FDA Grants Complete Approval For GSK's Jemperli For Endometrial Cancer

The FDA has granted full approval to GSK plc's GSK Jemperli (dostarlimab-gxly) for mismatch repair-deficient (dMMR) recurrent or advanced endometrial cancer.
The approval covers patients who progressed on or following a prior platinum-containing regimen in any setting and are not candidates for curative surgery or radiation.
In April 2021, Jemperli received accelerated approval.
The approval is based on additional data from the A1 expansion cohort of the ongoing GARNET trial, a phase 1 study of Jemperli monotherapy in patients with advanced or recurrent solid tumors.
Related: FDA Approves First Oral Treatment For Anemia Due To Chronic Kidney Disease.
Cohort A1 evaluated the efficacy of Jemperli in 141 patients with dMMR advanced or recurrent endometrial cancer that has progressed on or following prior treatment with a platinum-containing regimen.
The major efficacy outcome measures were overall response rate (ORR) and duration of response (DOR).
The confirmed overall response rate (ORR) was 45.4%, with a 15.6% complete response rate and a 29.8% partial response rate.
85.9% of patients had a duration of response ≥12 months and 54.7% of patients had a duration of response ≥24 months.
Price Action: GSK shares are down 1.24% at $35.98 during the premarket session on the last check Friday.