![]() ![]() ![]() The first agency-approved CAR T-cell therapy was tisagenlecleucel for the treatment of paediatric/AYAs with relapsed/refractory BCP-ALL (approved by the FDA in 2017 and EMA in 2018). CAR T-cells were first used to treat advanced non-Hodgkin lymphoma (NHL) in 2010, chronic lymphocytic leukaemia in 2011, paediatric and adolescent/young adult (AYA) B-cell precursor acute lymphoblastic leukaemia (BCP-ALL) in 2012 and most recently multiple myeloma. They facilitate the development of and scientifically driven discussion about the best choices of innovative medicines for the treatment of children with cancer and ultimately accelerate the introduction of these medicines into the standard of care for children. These Forums provided unprecedented opportunities for meaningful interaction between all stakeholders on topics that might cause a feasibility problem from an industry or academic standpoint in paediatric or adolescent cancer drug development. In this way, novel drugs with a similar mechanism of action can then be ‘compared’ in a non-competitive space, such that precious resources are not wasted, and paediatric patients are not enrolled on sub-optimal clinical studies. ![]() This is achieved by providing a unique opportunity to facilitate dialogue and enable constructive interactions between all stakeholders (regulators, pharmaceutical companies, clinical academics and patient advocates) on topics requiring discussion in drug development in children and adolescents with malignancy. ] is to share information between all stakeholders in a pre-competitive setting to inform paediatric drug development strategies and subsequent decisions. ![]()
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |