Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that MSI-H status confers therapeutic sensitivity to Pembrolizumab in patients with Esophagogastric Adenocarcinoma.
The European Medicines Agency (EMA) has authorized pembrolizumab as a monotherapy for the treatment of adult patients with microsatellite instability high (MSI-H) or mismatch repair deficiency (dMMR) unresectable or metastatic gastric, small intestine, or biliary cancer, who have disease progression on or following at least one prior therapy.
This statement is based on a regulatory approval from the European Medicines Agency:
KEYTRUDA as monotherapy is indicated for the treatment of the following MSI-H or dMMR tumours in adults with unresectable or metastatic gastric, small intestine, or biliary cancer, who have disease progression on or following at least one prior therapy.