The tools for the governance of mutational oncology and agnostic drugs: from place in therapy to place in pathway.

Abstract

In the oncology, the construction, implementation and evaluation of the care pathway must consider the integration of the "histological approach" with the "mutational" one, focused on the identification of specific molecular alterations to which the so-called "agnostic drugs" are targeted. To investigate this issue, a specific Working Group of the MaCroScopio Project (observatory on chronicity) was held in which the leading Italian experts in the oncology and regulatory field participated. From their articles, collected in this dossier, it clearly emerges the need of appropriate tools to manage the intrinsic complexity of the new mutational model and the challenges posed by agnostic drugs; among these Molecular Tumor Board, care pathway and Real-World Data. All this, to promote, for new oncological drugs, the transition from the classic study of the "place in therapy" to the "place in pathway", aimed to build the clinical, regulatory and institutional bases on which mutational oncology is based and make it a reality for all patients who need it.