Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that PD-L1 >= 50%, Wild type ALK, Wild type EGFR 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 first-line treatment of metastatic non-small cell lung carcinoma in adult patients whose tumors express PD-L1 with a >= 50% tumor proportion score (TPS) with no EGFR or ALK positive tumor mutations.
This statement is based on a regulatory approval from the European Medicines Agency:
KEYTRUDA as monotherapy is indicated for the first-line treatment of metastatic non-small cell lung carcinoma in adults whose tumours express PD-L1 with a >= 50% tumour proportion score (TPS) with no EGFR or ALK positive tumour mutations.