Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that PD-L1 >= 1% status confers therapeutic sensitivity to Durvalumab in patients with Non-Small Cell Lung Cancer.
The European Medicines Agency (EMA) has authorized durvalumab as a monotherapy for the treatment of adult patients with locally advanced, unresectable non-small cell lung cancer (NSCLC) whose tumors express PD-L1 on >= 1% of tumor cells and whose disease has not progressed following platinum-based chemoradiation therapy.
This statement is based on a regulatory approval from the European Medicines Agency:
IMFINZI as monotherapy is indicated for the treatment of locally advanced, unresectable non-small cell lung cancer (NSCLC) in adults whose tumours express PD-L1 on >= 1% of tumour cells and whose disease has not progressed following platinum-based chemoradiation therapy.