Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that MSI-H status confers therapeutic sensitivity to Pembrolizumab in patients with Colorectal 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) colorectal cancer as a first line-treatment for metastatic colorectal cancer or treatment of unresectable or metastatic colorectal cancer after previously fluoropryimidine-based combination therapy.
This statement is based on a regulatory approval from the European Medicines Agency:
KEYTRUDA as monotherapy is indicated for adults with MSI-H or dMMR colorectal cancer in the following settings: first-line treatment of metastatic colorectal cancer; treatment of unresectable or metastatic colorectal cancer after previous fluoropyrimidine -based combination therapy.