Making Genuine Progress Against Metastatic Breast Cancer
Ces deux articles analysent la controverse relative au retrait récent de l'autorisation de mise sur le marché, par les autorités réglementaires américaines, du bevacizumab dans le traitement d'un cancer métastatique du sein
Few drugs in oncology have generated as much discussion in both the medical literature and the popular and financial press as has bevacizumab for advanced breast cancer. The recent decision on the part of the US Food and Drug Administration (FDA) not to grant full approval for bevacizumab for first-line metastatic breast cancer (MBC) after granting accelerated approval 3 years earlier has sparked renewed debate about the oncology drug approval process and how best to measure clinical benefit in the setting of advanced cancer. Some have argued that the drug approval criteria are inconsistent and that regulatory standards are endangering progress in the treatment of MBC. Fortunately, that is not the case. Indeed, the experience with bevacizumab may illustrate how better to achieve rapid innovation and true progress in advanced breast cancer...
Journal of Clinical Oncology , résumé, 2012