Einsatz von Arzneimitteln außerhalb der Zulassung – Conditio sine qua non in der Präzisionsonkologie?

The task of precision oncology is to derive treatment recommendations for difficult-to-treat and rare cancers from molecular signatures of individual tumors. These personalized treatment recommendations are based on deep understanding of drivers of disease progression for the individual cancer and often include recommendation of drugs without license for the respective cancer or situation. Therefore, treatments within clinical trials and individual off-label treatments within prospective registry trials are a prerequisite for knowledge-generating cancer care. Patient counseling and diagnostics should be performed in specialized centers, whereas the treatment itself can be delivered in existing structures close to home.