ALK and non-small cell lung carcinoma: For instance, TTD endpoint results for the patient-reported concepts of “shortness of breath” (FDA) and cough, pain and dyspnea (EMA) were included in the prescribing/product information for ceritinib (Zykadia®), approved for patients with metastatic anaplastic lymphoma kinase (ALK)-positive Non-small cell lung cancer (NSCLC) [61, 62].