Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that PD-L1 >= 50%, Wild type ALK, Wild type EGFR, Wild type ROS1 status confers therapeutic sensitivity to Cemiplimab in patients with Non-Small Cell Lung Cancer.
The European Medicines Agency (EMA) has authorized cemiplimab as a monotherapy for the first-line treatment of adult patients with non-small cell lung cancer (NSCLC) expressing PD-L1 (in >= 50% of tumor cells), with no EGFR, ALK, or ROS1 aberrations. This indication is specifically for patients who have locally advanced NSCLC who are not candidates for definitive chemoradiation, or patients with metastatic NSCLC.
This statement is based on a regulatory approval from the European Medicines Agency:
LIBTAYO as monotherapy is indicated for the first-line treatment of adult patients with non-small cell lung cancer (NSCLC) expressing PD-L1 (in >= 50% tumour cells), with no EGFR, ALK or ROS1 aberrations, who have locally advanced NSCLC who are not candidates for definitive chemoradiation, or metastatic NSCLC.