Scientific Poster
Evidence Generation in an Early Access Strategy for Targeted Oncology Therapies: A Comparison in Non-Small Cell Lung Cancer
Nov 13, 2018
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There is large unmet need in non-small cell lung cancer (NSCLC), which remains the most common cause of cancerrelated mortality worldwide (1). In order to address this unmet need in a timely manner, patients should be provided early access to new treatment options. Conditional marketing authorization (CMA) is a regulatory route offered by the European Medicines Agency (EMA) specifically designed to accelerate patient access to new treatments in areas of high unmet need. CMA is associated with less comprehensive clinical trial data than is required for a standard “full” MA, on the condition that the applicant will provide this data within a specified timeframe. Besides trial data, sponsors may explore other evidence generation approaches.

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