Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that dMMR status confers therapeutic sensitivity to Pembrolizumab in patients with Gastrointestinal Stromal Tumor.
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.