Reevaluating the Accelerated Approval Process for Oncology Drugs
Cet article propose de nouvelles approches pour faciliter l'autorisation de mise sur le marché de nouveaux traitements en oncologie
In order for a new therapy to qualify for the accelerated approval pathway, it must treat a serious disease for which there is "unmet medical need"-- defined as providing a therapy where none exists or providing a therapy which may be potentially superior to existing therapy. The increasing number of available therapies, coupled with the lack of accepted endpoints considered "reasonably likely to predict clinical benefit" and the lack of clarity early in development regarding circumstances in which a new product will qualify for accelerated approval, is pushing developers to pursue accelerated approval in heavily pre-treated patients in order to fulfill an unmet need. To optimize the accelerated approval pathway, we propose here a reevaluation of what constitutes "unmet medical need" and "available therapy" in oncology. We also discuss ways for new endpoints to become qualified for use in supporting accelerated approval, and propose a structured process to pursuing accelerated approval.
Clinical Cancer Research , résumé, 2013