Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that pMMR status confers therapeutic sensitivity to Pembrolizumab in patients with Endometrial Carcinoma.
The U.S. Food and Drug Administration granted approval to pembrolizumab for the treatment of patients with advanced endometrial carcinoma that is mismatch repair deficient (MMRd) or microsatellite instability-high (MSI-H), as determined by an FDA-approved test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.
This statement is based on a regulatory approval from the Food and Drug Administration:
KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated as a single agent, for the treatment of patients with advanced endometrial carcinoma that is MSI-H or dMMR, as determined by an FDA-approved test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.