The option of compassionate use in metastatic melanoma - way out of a therapeutic dilemma?
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.
Tsianakas
Athanasios
A
Department of Dermatology, University of Münster, Germany. Athanasios.Tsianakas@ukmuenster.de
Schiller
Meinhard
M
Luger
Thomas A
TA
Sunderkötter
Cord
C
D017277:Drug Approval / Q000331:legislation & jurisprudence; D015507:Drugs, Investigational / Q000627:therapeutic use*; D004645:Empathy; D005858:Germany / Q000453:epidemiology; D017408:Guidelines as Topic; D006801:Humans; D008545:Melanoma / Q000188:drug therapy* / Q000556:secondary*; D012878:Skin Neoplasms / Q000188:drug therapy* / Q000556:secondary*
D015507:Drugs, Investigational