Evaluation and regulation of oncology drug approval: Finding the right balance

A partir d'une analyse des procès-verbaux de 84 réunions du comité d'experts en oncologie de la Food and Drug Administration entre 2000 et 2014, cette étude évalue les facteurs associés aux recommandations d'autorisation de mise sur le marché, notamment l'influence des conflits d'intérêts financiers déclarés par les experts

Résumé en anglais

In 2015, the US Food and Drug Administration (FDA) approved 18 new drugs and biologic agents in the treatment of cancer and added nearly as many new indications or formulations to existing drug labels. Recent surveys1,2 have demonstrated that oncology drugs are more likely and rapidly approved in the United States than in either Europe or Canada. With nearly 800 new cancer drugs and vaccines currently in development, the recent increase in the pace of cancer drug approval in the United States perhaps comes with little surprise. Nevertheless, concern has frequently been expressed that the FDA is too close to the companies that it regulates and that the recent speed of drug approval is largely the result of lower standards for evaluating drug efficacy and less attention to issues of drug safety. In a recent examination3 of new drug applications for oncology drugs over the past decade, the FDA found only 15 that elicited a nonapproval decision, of which 10 failed for lack of efficacy and 5 for clinical trial design flaws, while no application was rejected solely on the basis of safety.