Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
4215487 | Revue des Maladies Respiratoires Actualités | 2015 | 14 Pages |
Abstract
There is no good definition of therapeutic innovation. In the field of lung cancer, it seems that it is the amount of life gained that best defines therapeutic innovation for the public and for healthcare professionals. The drugs must undergo a long and multi steps development to reach their marketing authorization. Such development is very costly for industrial and therapeutic innovation weighs heavily on societal expenses, due to reimbursement of treatment. The concept of targeted therapy coupled with its predictive biomarker has streamlined and shorten delays in obtaining marketing authorization, but nivolumab - an anti-PD1 antibody, got rapidly its authorization in the treatment of squamous cell carcinoma, without any predictive biomarker. Regulatory agencies have also introduced accelerated assessment procedures, such as conditional marketing authorization. The explosion of molecular biology techniques has also uncovered a large number of rare oncogenic addictions, but sometimes shared by different cancers, leading to new types of therapeutic trials, such as “basket” trials, to evaluate their efficacy. Finally, France offers a unique regulatory system through their autorisations temporaires d'utilisation (ATU) and recommandations temporaires d'utilisation (RTU) to provide for all - or nearly all - access to therapeutic innovations.
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Authors
J. Cadranel, P. Créquit, T. Vieira, A.-M. Ruppert, V. Gounant, A. Lavolé, M. Wislez,