The option of compassionate use in metastatic melanoma - way out of a therapeutic dilemma?
Tsianakas A, Schiller M, Luger TA, Sunderkötter C
Research article (journal)Abstract
Metastasized melanoma has an unfavorable prognosis. Therefore there is strong need for new innovative therapies. In cases in which standard therapies have failed and inclusion in clinical studies is not possible due to diverse causes, the option of compassionate use now opens new therapeutic windows. Compassionate use describes the use of not (yet) approved drugs for humanitarian reasons. It was legally established in Germany through drug laws issued in 2006. We describe legal aspects of compassionate use are discussed, taking two of our cases as examples. Finally, examples for necessary documents to apply for compassionate use are provided.
Details about the publication
Journal: Journal der Deutschen Dermatologischen Gesellschaft (JDDG)
Volume: 7
Issue: 8
Page range: 671-679
Status: Published
Release year: 2009
Language in which the publication is written: English
Keywords: Humans; Empathy; Melanoma; Drugs Investigational; Skin Neoplasms; Drug Approval; Germany; Guidelines as Topic; Humans; Empathy; Melanoma; Drugs Investigational; Skin Neoplasms; Drug Approval; Germany; Guidelines as Topic
Authors from the University of Münster
| Luger, Thomas | Clinic for Dermatology |
| Schiller, Meinhard | Clinic for Dermatology |
| Sunderkötter, Cord | Clinic for Dermatology |
| Tsianakas, Athanasios | Clinic for Dermatology |