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Annals of Oncology 2007 18(12):1923-1925; doi:10.1093/annonc/mdm517
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© 2007 European Society for Medical Oncology

editorials

The off-label use of drugs in oncology: a position paper by the European Society for Medical Oncology (ESMO)

P. G. Casali On behalf of the Executive Committee of ESMO

Istituto Nazionale Tumori, Milano, Italy

(E-mail: paolo.casali@istitutotumori.mi.it)

The first 150 words of the full text of this article appear below.

All drugs need to be given a marketing authorization by a relevant regulatory body in order for patients to receive them [1]. The marketing authorization is granted if the drug is judged to be safe and effective for a given indication following a given administration regimen. This is the drug ‘label’. When the drug is used for other indications, it is used ‘off label’.

This is different from when a drug is ‘unlicensed’. In this case, the drug is not accessible on the market, and, in principle, its use can take place only within clinical studies, or a compassionate/expanded access setting, generally being provided for free by the pharmaceutical company.

The off-label use of drugs in oncology has been estimated to reach 50%, or even more [2–4]. In pediatrics, the off-label issue is particularly widespread, all the more in pediatric oncology [5]. . . . [Full Text of this Article]

The problem needs to be urgently addressed
Regulatory bodies should take responsibility
Lists of acceptable drugs should be worked out
The initiative of seeking label extensions, or the mechanisms to expand drugs uses, should not depend exclusively on pharmaceutical companies

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