Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that PD-L1 >= 1%, Wild type ALK, Wild type EGFR status confers therapeutic sensitivity to Pembrolizumab in patients with Non-Small Cell Lung Cancer.
The U.S. Food and Drug Administration granted approval to pembrolizumab for the first-line treatment of patients with non-small cell lung cancer expressing PD-L1 [Tumor Proportion Score (TPS) >=1%], as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and is: Stage III where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic.
This statement is based on a regulatory approval from the Food and Drug Administration:
KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated as a single agent for the first-line treatment of patients with NSCLC expressing PD-L1 [Tumor Proportion Score (TPS) >=1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and is: Stage III where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic.