Cancer drugs approved on the basis of a surrogate end point and subsequent overall survival: An analysis of 5 years of us food and drug administration approvals
A partir de données portant sur les autorisations de mise sur le marché (AMM) de médicaments anticancéreux délivrées par l'autorité réglementaire américaine entre 2008 et 2012, cette étude analyse le nombre de traitements qui, ayant reçu une AMM sur la base d'un critère de jugement de substitution, ont démontré ultérieurement une amélioration de la survie globale
Most contemporary approvals of new cancer drugs are made on the basis of a surrogate end point, such as response rate or progression-free survival (PFS). When the approval is based on a surrogate end point, subsequent studies are advised and often obligated to clarify the drug’s effect on overall survival. One such drug is bevacizumab, which received accelerated approval on the basis of PFS for patients with metastatic breast cancer. Later findings revealed no improvement in overall survival and significant toxicity, which required a removal of marketing authorization.
JAMA Internal Medicine , résumé, 2014