US FDA grants accelerated approval to dostarlimab-gxly for the treatment of recurrent or advanced endometrial cancer
Approval of the PD-1 blocking antibody is specifically for its use in adults with mismatch repair-deficient (dMMR) recurrent or advanced endometrial cancer, that has progressed on or following prior treatment with a platinum-containing regimen.
Source:
US Food and Drug Administration
SPS commentary:
Approval was based on the results of cohort A1 in the GARNET trial, in which the confirmed overall response rate was 42.3% (95% CI 30.6% to 54.6%). Median duration of response was not reached, with 93.3% having a duration of at least 6 months.
In February 2021, the European CHMP granted a positive opinion, recommending approval of dostarlimab for the same indication.