Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that PD-L1 >= 1% status confers therapeutic sensitivity to Pembrolizumab in patients with Non-Small Cell Lung Cancer.
The European Medicines Agency (EMA) has authorized pembrolizumab as a monotherapy for the treatment of adult patients with locally advanced or metastatic non-small cell lung carcinoma whose tumors express PD-L1 with a >= 1% tumor proportion score (TPS) and who have recieved at least one prior chemotherapy regime. Patients with EGFR or ALK positive tumor mutations should also have received targeted therapy before receiving pembrolizumab.
This statement is based on a regulatory approval from the European Medicines Agency:
KEYTRUDA as monotherapy is indicated for the treatment of locally advanced or metastatic non-small cell lung carcinoma in adults whose tumours express PD-L1 with a >= 1% TPS and who have received at least one prior chemotherapy regimen. Patients with EGFR or ALK positive tumour mutations should also have received targeted therapy before receiving KEYTRUDA.