Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that dMMR status confers therapeutic sensitivity to Dostarlimab in patients with Any solid tumor.
The U.S. Food and Drug Administration granted accelerated approval to dostarlimab for the treatment of adult patients with mismatch repair deficient (dMMR) recurrent or advanced solid tumors, as determined by an FDA-Approved test, that have progressed on or following prior treatment and who have no satisfactory alternative treatment options.
This statement is based on a regulatory approval from the Food and Drug Administration:
JEMPERLI is a programmed death receptor-1 (PD-1)-blocking antibody indicated as a single agent for the treatment of adult patients with dMMR recurrent or advanced solid tumors, as determined by an FDA-approved test, that have progressed on or following prior treatment and who have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).