For example, the osimertinib EAP was developed to provide compassionate access to osimertinib in the USA after enrolment in clinical trials had closed, but prior to FDA approval for patients with advanced or metastatic EGFR T790M-positive non-small cell lung cancer following progression on prior EGFR-TKI therapy (22). Trials with integrated EAP are clearly described as expanded access in the ClinicalTrials.gov register, but frequently only referred to as open-label extension studies in the EU register (12). The gene discussed is EGFR; the disease is non-small cell lung carcinoma.