Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that PD-L1 >= 50%, Wild type ALK, Wild type EGFR, dMMR status confers therapeutic sensitivity to Cemiplimab in patients with Non-Small Cell Lung Cancer.
The U.S. Food and Drug Administration granted approval to cemiplimab for the first-line treatment of adult patients with NSCLC whose tumors have high PD-L1 expression [Tumor Proportion Score (TPS) >= 50%] as determined by an FDA-approved test, with no EGFR, ALK or ROS1 aberrations, and is: (i) locally advanced where patients are not candidates for surgical resection or definitive chemoradiation or (ii) metastatic.
This statement is based on a regulatory approval from the Food and Drug Administration:
LIBTAYO is a programmed death receptor-1 (PD-1) blocking antibody indicated as single agent for the first-line treatment of adult patients with NSCLC whose tumors have high PD-L1 expression [Tumor Proportion Score (TPS) >= 50%] as determined by an FDA-approved test, with no EGFR, ALK or ROS1 aberrations, and is: (i) locally advanced where patients are not candidates for surgical resection or definitive chemoradiation or (ii) metastatic.